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WIZMED sources is data from the FDA, Dailymed, Medicaid data and other data sources. The data feeds run night, weekly and/or quarterly depending on data source. WIZMED nor any of its agencies, contractors, subcontractors or employees does not make any warranties, expressed or implied, with respect to data contained in these databases or files, and, furthermore, assume no liability for any party's use, or the results of such use, of any part of the database or files.

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Ipca Laboratories Limited India 2019-08-23

Latest FDA warning letters below, this is updated weekly with the latest FDA warning letters.

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Monitor latest FDA approvals

MFG Route Drug Strength NDCs Type Approval Date PI Labels
Par Pharmaceuti intravenous, subcutaneous treprostinil 5 mg/mL 42023-208-01 ANDA 2019-09-25
Par Pharmaceuti intravenous, subcutaneous treprostinil 2.5 mg/mL 42023-207-01 ANDA 2019-09-25
Par Pharmaceuti intravenous, subcutaneous treprostinil 10 mg/mL 42023-209-01 ANDA 2019-09-25
AvKARE, Inc. oral phenazopyridine hydrochloride 100 mg/1 42291-737-90 UNAPPROVED DRUG OTHER 2019-09-23
Par Pharmaceuti intravenous, subcutaneous treprostinil 1 mg/mL 42023-206-01 ANDA 2019-09-25
AvKARE, Inc. oral phenazopyridine hydrochloride 200 mg/1 42291-738-90 UNAPPROVED DRUG OTHER 2019-09-23
Micro Labs Limi topical clobetasol propionate .5 mg/mL 42571-362-99, 42571-362-81 ANDA 2019-10-02
Par Pharmaceuti oral trientine hydrochloride 250 mg/1 49884-060-01 ANDA 2019-09-27
AvPAK oral anastrozole 1 mg/1 50268-075-15 ANDA 2019-10-11
AvPAK oral levetiracetam 100 mg/mL 50268-470-13 ANDA 2019-10-14
AvPAK oral celecoxib 100 mg/1 50268-168-15 ANDA 2019-10-17
AvPAK oral clopidogrel bisulfate 300 mg/1 50268-184-12 ANDA 2019-10-11
AvPAK oral celecoxib 200 mg/1 50268-169-15 ANDA 2019-10-17
Ingenus Pharmac topical clobetasol propionate .5 mg/g 50742-311-60, 50742-311-30, 50742-311-15 ANDA 2019-10-16
Ingenus Pharmac intravenous decitabine 50 mg/1 50742-430-01 ANDA 2019-09-24
HF Acquisition intramuscular, intravenous metoclopramide 10 mg/2mL 51662-1367-1 ANDA 2019-10-14
HF Acquisition intramuscular, intravenous hydralazine hydrochloride 20 mg/mL 51662-1388-1 ANDA 2019-10-07
HF Acquisition intramuscular, intravenous magnesium sulfate 500 mg/mL 51662-1390-1 NDA 2019-10-07
HF Acquisition oral nitroglycerin lingual 400 ug/1 51662-1393-1 ANDA 2019-10-09
HF Acquisition intravenous protamine sulfate 10 mg/mL 51662-1414-1 ANDA 2019-10-13
HF Acquisition infiltration, perineural chloroprocaine hci 20 mg/mL 51662-1401-1 NDA 2019-10-13
HF Acquisition intramuscular, intravenous dexamethasone sodium phosphate 4 mg/mL 51662-1370-1 ANDA 2019-10-13
HF Acquisition infiltration, perineural (chloroprocaine hci 10 mg/mL 51662-1407-1 NDA 2019-10-13
HF Acquisition parenteral atropine sulfate .1 mg/mL 51662-1378-1 UNAPPROVED DRUG OTHER 2019-10-15
HF Acquisition intramuscular, intravenous procainamide hci 500 mg/mL 51662-1392-1 ANDA 2019-10-16
HF Acquisition perineural bupivacaine hydrochloride 5 mg/mL 51662-1396-1 ANDA 2019-10-16
HF Acquisition intramuscular, intravenous magnesium sulfate 500 mg/mL 51662-1372-1 NDA 2019-10-14
HF Acquisition intravenous potassium chloride 149 mg/mL 51662-1387-1 ANDA 2019-10-16
HF Acquisition intramuscular, intravenous dexamethasone sodium phosphate 10 mg/mL 51662-1391-1 ANDA 2019-10-08
HF Acquisition infiltration, perineural sensorcaine(r) (bupivacaine hci and epinephrine) 2.5 mg/mL, .005 mg/mL 51662-1397-1 ANDA 2019-10-08
HF Acquisition intravenous verapamil hydrochloride 2.5 mg/mL 51662-1398-1 ANDA 2019-10-17
HF Acquisition intramuscular, intravenous pyridoxine hci 100 mg/mL 51662-1410-1 ANDA 2019-10-08
HF Acquisition epidural, infiltration, intracaudal, perineural lidocaine hci and epinephrine with epinephrine .005 mg/mL, 20 mg/mL 51662-1412-1 NDA 2019-10-14
HF Acquisition intravenous 5% dextrose 5 g/100mL 51662-1413-1 NDA 2019-10-14
HF Acquisition intramuscular, intravenous, subcutaneous naloxone hydrochloride .4 mg/mL 51662-1385-1 ANDA 2019-10-15
General Injecta oral clonidine hydrochloride .1 mg/1 52584-094-20 ANDA 2019-10-10
HF Acquisition intravenous nitroglycerin 5 mg/mL 51662-1386-1 ANDA 2019-10-07
HF Acquisition intravenous doxy 100(tm) doxycycline 100 mg/10mL 51662-1402-1 ANDA 2019-10-07
BPI Labs LLC subcutaneous hyoscyamine sulfate .5 mg/mL 54288-111-05 UNAPPROVED DRUG OTHER 2019-10-18
AuroMedics Phar intramuscular, intravenous, subcutaneous naloxone hydrochloride .4 mg/mL 55150-327-25, 55150-327-10 ANDA 2019-10-15
Quality Care Pr topical diclofenac epolamine 180 mg/1 55700-801-30 NDA AUTHORIZED GENERIC 2019-10-11
Quality Care Pr oral lisinopril and hydrochlorothiazide 20 mg/1, 25 mg/1 55700-799-30 ANDA 2019-10-11
Quality Care Pr oral meclizine hydrochloride 25 mg/1 55700-800-30 ANDA 2019-10-11
Quality Care Pr oral oseltamivir phosphate 6 mg/mL 55700-798-60 ANDA 2019-10-11
Clinical Soluti oral olanzapine 5 mg/1 58118-0381-8 ANDA 2019-10-10
WINDLAS HEALTHC oral amiloride hydrochloride 5 mg/1 57721-671-01, 57721-671-16, 57721-671-10, 57721-671-30, 57721-671-06, 57721-671-05 ANDA 2019-10-14
Clinical Soluti oral lamotrigine 25 mg/1 58118-1111-8 ANDA 2019-10-08
Clinical Soluti oral venlafaxine hydrochloride 75 mg/1 58118-0335-8 ANDA 2019-10-08
American Health oral levothyroxine sodium .175 mg/1 60687-541-01 ANDA 2019-10-01
American Health oral levothyroxine sodium .05 mg/1 60687-464-01 ANDA 2019-10-01
American Health oral levothyroxine sodium .088 mg/1 60687-486-01 ANDA 2019-10-01
American Health oral cinacalcet 30 mg/1 60687-525-21 ANDA 2019-10-15
St. Mary's Medi oral fenofibrate 160 mg/1 60760-411-30 ANDA 2019-10-02
American Health oral levothyroxine sodium .025 mg/1 60687-453-01 ANDA 2019-10-01
St. Mary's Medi topical lidocaine 50 mg/g 60760-201-30 ANDA 2019-10-10
St. Mary's Medi oral buspirone hydrochloride 15 mg/1 60760-548-60 ANDA 2019-10-15
American Health oral levothyroxine sodium .112 mg/1 60687-508-01 ANDA 2019-10-01
American Health oral valproic acid 250 mg/5mL 60687-262-56 ANDA 2019-10-15
American Health oral levothyroxine sodium .075 mg/1 60687-475-01 ANDA 2019-10-01
American Health oral levothyroxine sodium .1 mg/1 60687-497-01 ANDA 2019-10-01
American Health oral levothyroxine sodium .125 mg/1 60687-519-01 ANDA 2019-10-01
American Health oral levothyroxine sodium .15 mg/1 60687-530-01 ANDA 2019-10-01
St. Mary's Medi oral promethazine hydrochloride 25 mg/1 60760-456-20 ANDA 2019-10-09
St. Mary's Medi oral ondansetron 4 mg/1 60760-277-10 ANDA 2019-10-02
St. Mary's Medi topical lidocaine 50 mg/g 60760-473-35 ANDA 2019-10-15
St. Mary's Medi oral carisoprodol 350 mg/1 60760-397-90 ANDA 2019-10-15
Direct_Rx oral levothyroxine sodium 125 ug/1 61919-549-30, 61919-549-90 NDA 2019-10-08
Direct_Rx oral tizanidine 4 mg/1 61919-221-15 ANDA 2019-09-30
Alembic Pharmac topical clobetasol propionate .05 g/mL 62332-425-59, 62332-425-12 ANDA 2019-10-16
Fresenius Kabi intramuscular, intravenous ertapenem sodium 1 g/1 63323-823-20 ANDA 2019-10-10
Strides Pharma oral losartan potassium 50 mg/1 64380-934-04, 64380-934-06, 64380-934-07, 64380-934-08, 64380-934-05 ANDA 2019-10-09
Strides Pharma oral losartan potassium 100 mg/1 64380-935-08, 64380-935-07, 64380-935-04, 64380-935-05, 64380-935-06 ANDA 2019-10-09
Strides Pharma oral losartan potassium 25 mg/1 64380-933-06, 64380-933-05, 64380-933-04, 64380-933-07, 64380-933-08 ANDA 2019-10-09
Amneal Pharmace oral paliperidone 6 mg/1 65162-282-09, 65162-282-03 ANDA 2019-09-24
AstraZeneca Pha intramuscular fulvestrant 50 mg/mL 0310-7720-10 NDA AUTHORIZED GENERIC 2019-10-08
Amneal Pharmace oral paliperidone 9 mg/1 65162-283-09, 65162-283-03 ANDA 2019-09-24
Amneal Pharmace oral paliperidone 1.5 mg/1 65162-280-03, 65162-280-09 ANDA 2019-09-24
Amneal Pharmace oral paliperidone 3 mg/1 65162-281-09, 65162-281-03 ANDA 2019-09-24
AstraZeneca Pha subcutaneous benralizumab 30 mg/mL 0310-1830-85, 0310-1830-30 BLA 2019-10-04
Galderma Labora topical trifarotene 50 ug/g 0299-5935-45, 0299-5935-75, 0299-5935-02, 0299-5935-30 NDA 2019-10-04
Kadmon Pharmace oral trientine hydrochloride 250 mg/1 66435-700-10 ANDA 2019-09-30
VistaPharm, Inc oral digoxin .05 mg/mL 66689-327-02 ANDA 2019-10-04
Prasco Laborato topical ivermectin 10 mg/g 66993-948-48 NDA AUTHORIZED GENERIC 2019-10-15
Ascend Laborato oral pregabalin 25 mg/1 67877-462-90, 67877-462-38, 67877-462-33, 67877-462-30, 67877-462-05 ANDA 2019-10-02
Ascend Laborato oral pregabalin 50 mg/1 67877-463-05, 67877-463-30, 67877-463-33, 67877-463-38, 67877-463-90 ANDA 2019-10-02
BluePoint Labor oral gabapentin 800 mg/1 68001-412-03, 68001-412-00 ANDA 2019-09-30
BluePoint Labor oral gabapentin 600 mg/1 68001-411-00, 68001-411-03 ANDA 2019-09-30
Gland Pharma Li intramuscular, intravenous glycopyrrolate .2 mg/mL 68083-378-25 ANDA 2019-10-09
Gland Pharma Li intramuscular, intravenous glycopyrrolate .2 mg/mL 68083-377-25 ANDA 2019-10-09
Gland Pharma Li intramuscular, intravenous glycopyrrolate .2 mg/mL 68083-376-25 ANDA 2019-10-09
Gland Pharma Li intramuscular, intravenous glycopyrrolate .2 mg/mL 68083-379-10 ANDA 2019-10-09
Lupin Pharmaceu oral atorvastatin calcium 20 mg/1 68180-636-09, 68180-636-06, 68180-636-02 ANDA 2019-10-06
Lupin Pharmaceu oral atorvastatin calcium 40 mg/1 68180-637-09, 68180-637-06, 68180-637-02 ANDA 2019-10-06
Lupin Pharmaceu oral atorvastatin calcium 10 mg/1 68180-635-09, 68180-635-06, 68180-635-02 ANDA 2019-10-06
Lupin Pharmaceu oral atorvastatin calcium 80 mg/1 68180-638-09, 68180-638-02, 68180-638-06 ANDA 2019-10-06
Preferred Pharm norgestimate and ethinyl estradiol 68788-7429-2 ANDA 2019-10-01
Zydus Pharmaceu oral colesevelam 625 mg/1 68382-619-10, 68382-619-28, 68382-619-77 ANDA 2019-10-11
Bionpharma Inc. oral omega-3-acid ethyl esters 900 mg/1 69452-175-22, 69452-175-17 ANDA 2019-10-15
Somerset Therap intramuscular haloperidol decanoate 50 mg/mL 70069-030-05, 70069-030-03 ANDA 2019-09-27
Somerset Therap intramuscular haloperidol decanoate 100 mg/mL 70069-031-05 ANDA 2019-09-27
Somerset Therap intramuscular haloperidol decanoate 100 mg/mL 70069-384-05 ANDA 2019-09-27
Somerset Therap intramuscular haloperidol decanoate 50 mg/mL 70069-381-10 ANDA 2019-09-27
Somerset Therap intramuscular haloperidol decanoate 50 mg/mL 70069-382-05 ANDA 2019-09-27
Somerset Therap intramuscular haloperidol decanoate 100 mg/mL 70069-383-10, 70069-383-05 ANDA 2019-09-27
REMEDYREPACK IN oral phenazopyridine hydrochloride 100 mg/1 70518-2330-0 UNAPPROVED DRUG OTHER 2019-09-27
REMEDYREPACK IN oral lithium carbonate 600 mg/1 70518-2345-0 NDA 2019-10-04
REMEDYREPACK IN oral fenofibrate 160 mg/1 70518-2349-0 ANDA 2019-10-06
REMEDYREPACK IN oral gabapentin 600 mg/1 70518-2356-0 ANDA 2019-10-09
REMEDYREPACK IN oral escitslopram 5 mg/1 70518-2362-0 ANDA 2019-10-11
REMEDYREPACK IN oral ciprofloxacin tablets 500 mg/1 70518-2341-0, 70518-2341-2, 70518-2341-1 ANDA 2019-10-03
REMEDYREPACK IN oral valacyclovir hydrochloride 500 mg/1 70518-2346-0 ANDA 2019-10-04
REMEDYREPACK IN oral olmesartan medoxomil 20 mg/1 70518-2347-0 ANDA 2019-10-04
REMEDYREPACK IN oral enalapril maleate 5 mg/1 70518-2348-0 NDA AUTHORIZED GENERIC 2019-10-04
REMEDYREPACK IN oral gabapentin 800 mg/1 70518-2323-0, 70518-2323-1, 70518-2323-2 ANDA 2019-09-24
REMEDYREPACK IN topical lidocaine 50 mg/g 70518-2355-0 ANDA 2019-10-09
REMEDYREPACK IN oral divalproex sodium 500 mg/1 70518-2357-0 ANDA 2019-10-10
REMEDYREPACK IN oral finasteride 5 mg/1 70518-2363-0 ANDA 2019-10-16
REMEDYREPACK IN oral hydroxyzine pamoate 50 mg/1 70518-2350-0 ANDA 2019-10-08
REMEDYREPACK IN oral pregabalin 100 mg/1 70518-2364-0 ANDA 2019-10-16
Novitium Pharma oral digoxin .05 mg/mL 70954-154-10 ANDA 2019-10-04
REMEDYREPACK IN respiratory (inhalation) ipratropium bromide and albuterol sulfate 2.5 mg/3mL, .5 mg/3mL 70518-2351-0 ANDA 2019-10-07
REMEDYREPACK IN topical clotrimazole and betamethasone dipropionate 10 mg/g, .5 mg/g 70518-2352-0 ANDA 2019-10-08
REMEDYREPACK IN oral olanzapine 20 mg/1 70518-2337-0 ANDA 2019-10-02
REMEDYREPACK IN oral sulfasalazine 500 mg/1 70518-2342-0 ANDA 2019-10-03
REMEDYREPACK IN oral lamotrigine 100 mg/1 70518-2343-0 ANDA 2019-10-03
REMEDYREPACK IN topical mupirocin 20 mg/g 70518-2344-0 ANDA 2019-10-04
Cadila Healthca oral colesevelam 625 mg/1 70771-1368-4, 70771-1368-0, 70771-1368-8 ANDA 2019-10-11
Circassia Pharm respiratory (inhalation) aclidinium bromide and formoterol fumarte 400 ug/1, 12 ug/1 72124-001-03, 72124-001-01 NDA 2019-10-11
Direct_Rx topical diclofenac sodium 30 mg/g 72189-040-01 ANDA 2019-10-08
Direct_Rx oral potassium chloride 750 mg/1 72189-027-30 ANDA 2019-10-02
Nivagen Pharmac oral nateglinide 120 mg/1 75834-206-01 ANDA 2019-09-25
Direct_Rx oral valsartan 80 mg/1 72189-049-30 ANDA 2019-10-08
Direct_Rx oral valsartan 80 mg/1 72189-049-60 ANDA 2019-10-08
Direct_Rx oral valsartan 160 mg/1 72189-050-30 ANDA 2019-10-09
Nivagen Pharmac oral tizanidine hydrochloride 6 mg/1 75834-209-15 ANDA 2019-09-26
Direct_Rx oral phenazopyridine hydrochloride 100 mg/1 72189-047-06 UNAPPROVED DRUG OTHER 2019-09-30
Direct_Rx oral valsartan 80 mg/1 72189-049-90 ANDA 2019-10-08
Nivagen Pharmac oral tizanidine hydrochloride 4 mg/1 75834-208-15 ANDA 2019-09-26
Hospira, Inc. intravenous meropenem 500 mg/10mL 0409-1390-51 ANDA 2019-10-09
BWXT ITG Canada intravenous indium in-111 oxyquinoline 1 mCi/mL 72536-0920-1 ANDA 2019-09-27
Direct_Rx ophthalmic erythromycin 5 mg/g 72189-036-35 ANDA 2019-10-08
Nivagen Pharmac oral tizanidine hydrochloride 2 mg/1 75834-207-15 ANDA 2019-09-26
Nivagen Pharmac oral nateglinide 60 mg/1 75834-205-01 ANDA 2019-09-25
Hospira, Inc. intravenous meropenem 1 g/20mL 0409-1391-22 ANDA 2019-10-09
Actavis Pharma, topical ivermectin 10 mg/g 0591-4052-89 ANDA 2019-10-14
Teva Parenteral intravenous, subcutaneous treprostinil 50 mg/20mL 0703-0676-01 ANDA 2019-09-30
Teva Parenteral intravenous, subcutaneous treprostinil 100 mg/20mL 0703-0686-01 ANDA 2019-09-30
Teva Parenteral intravenous, subcutaneous treprostinil 20 mg/20mL 0703-0666-01 ANDA 2019-09-30
Teva Parenteral intravenous, subcutaneous treprostinil 200 mg/20mL 0703-0696-01 ANDA 2019-09-30
ICU Medical Inc intravenous dextrose monohydrate 5 g/100mL 0990-7922-25 NDA 2019-10-01
ICU Medical Inc urethral sorbitol and mannitol 2.7 g/100mL, .54 g/100mL 0990-7981-08 NDA 1982-01-01
ICU Medical Inc intravenous dextrose monohydrate 5 g/100mL 0990-7923-11, 0990-7923-06 NDA 2019-10-01
ICU Medical Inc intravenous water 1000 mL/1000mL 0990-7990-09 NDA 1982-01-01
Novartis Pharma intravitreal brolucizumab 6 mg/.05mL 0078-0827-99, 0078-0827-61 BLA 2019-10-07
Seton Pharmaceu respiratory (inhalation) pentamidine isethionate 300 mg/300mg 13925-522-01 ANDA 2019-10-14
Accord Healthca oral ezetimibe 10 mg/1 16729-433-15 ANDA 2019-10-07
Camber Pharmace oral omeprazole 20 mg/1 31722-528-01, 31722-528-30 ANDA 2019-09-26
Heritage Pharma carmustine 23155-649-41 NDA AUTHORIZED GENERIC 1982-01-01
Sagent Pharmace intravenous fluconazole 2 mg/mL 25021-184-67, 25021-184-66 ANDA 2019-10-15
Camber Pharmace oral omeprazole 10 mg/1 31722-527-01, 31722-527-30 ANDA 2019-09-26
Camber Pharmace oral pregabalin 50 mg/1 31722-611-90, 31722-611-60, 31722-611-32, 31722-611-31, 31722-611-05 ANDA 2019-10-08
Camber Pharmace oral pregabalin 75 mg/1 31722-612-90, 31722-612-05, 31722-612-60, 31722-612-31 ANDA 2019-10-08
Camber Pharmace oral pregabalin 200 mg/1 31722-615-05, 31722-615-60, 31722-615-31, 31722-615-90 ANDA 2019-10-08
Camber Pharmace oral pregabalin 300 mg/1 31722-617-60, 31722-617-90, 31722-617-32, 31722-617-31, 31722-617-05 ANDA 2019-10-08
Camber Pharmace oral pregabalin 225 mg/1 31722-616-60, 31722-616-31, 31722-616-90, 31722-616-05 ANDA 2019-10-08
Sagent Pharmace epidural, infiltration ropivacaine hydrochloride 2 mg/mL 25021-671-66, 25021-671-67 ANDA 2019-10-15
Camber Pharmace oral pregabalin 25 mg/1 31722-610-90, 31722-610-60, 31722-610-31, 31722-610-32, 31722-610-05 ANDA 2019-10-08
Camber Pharmace oral pregabalin 100 mg/1 31722-613-05, 31722-613-31, 31722-613-60, 31722-613-90 ANDA 2019-10-08
Camber Pharmace oral pregabalin 150 mg/1 31722-614-05, 31722-614-31, 31722-614-60, 31722-614-90 ANDA 2019-10-08

List of new API DMFs (drug master files) from FDA which is updated quarterly

Company Submit Date Subject

Abriged, not to be used by medical professionals, updated daily from the FDA website

Company Drug Reason NDCs Date Lot Quantity
Torrent Pharma Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-116-90 CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million. 13668-116-30, 13668-116-90, 13668-116-74, 13668-117-30, 13668-116-10, 13668-117-10, 13668-118-10, 13668-118-74, 13668-117-90, 13668-118-90, 13668-117-74, 13668-118-30 20191009 Lot BEF7D051 17,088 bottles
Torrent Pharma Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-118-90 CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million. 13668-116-30, 13668-116-90, 13668-116-74, 13668-117-30, 13668-116-10, 13668-117-10, 13668-118-10, 13668-118-74, 13668-117-90, 13668-118-90, 13668-117-74, 13668-118-30 20191009 Lot 4P04D007 8,688 bottles
Sandoz, Inc Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60 CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA). 0781-1884-31, 0781-1883-60, 0781-2865-05, 0781-2855-31, 0781-2865-92, 0781-1883-05, 0781-2855-05, 0781-1883-10, 0781-1883-01, 0781-2855-92, 0781-2855-60, 0781-1884-25, 0781-1884-10, 0781-2865-31 20191016 HC9266 4/30/2020 HD1865 4/30/2020 HP9441 9/30/2020 JK7994 8/31/2021 JK8659 8/31/2021 100,314 bottles
Unipharma, Llc. DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL) Each 3.4 fl. oz. (100 mL), Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321 UPC 370302489026 CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. 20191016 Lot: 80047 Exp. 07/31/20 144 cartons
Colonia Care Ph C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.88MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 071519E, BUD 08/29/19 1 vial
KRS Global Biot PHENYLephrine HCl in 0.9% Sodium Chloride (PF), 1 mg / 10 mL (0.1 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677379 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 15260 syringes
KRS Global Biot Hydroxocobalamin 10 mL Vial 5 mg/10 mL (0.5 mg/mL) For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678336 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 1528
KRS Global Biot Ketamine in 0.9% Sodium Chloride (PF) 50 mg/ 5mL (10 mg/mL) 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678093 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 11733 syringes
KRS Global Biot Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL), 0.5 mL Fill in a 3 mL Syringe, Sterile Ophthalmic Topical Solution, (Contains Sulfites), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677124 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 465 syringes
KRS Global Biot Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676632 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 1980 vials
KRS Global Biot Ascorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial--For SC/IM Use-Contains Sulfites, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321675033 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 602 vials
Pfizer Inc. Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made in Netherlands Distributed by Parke-Davis Division of Pfizer In NY, NY 10017, NDC 0071-0237-24 Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020. 0071-0237-24 20191002 Lot #3267079, Exp 09/2021 7,686 100-count bottles
Darmerica, LLC Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50 g NDC# 71052-530-55, c) 25g NDC# 71052-530-25, Darmerica LLC 198 Wilshire Blvd Casselberry, FL 32707 Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin. 20191002 Lot#: a) DL4654A, Exp. 04/27/21; b) DR4654, Exp. 04/27/21 c) DR4654, Exp. 04/27/21 1.8 kilograms
EPI Health, LLC minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physician Sample Not for Sale 5 Tablets, Rx Only, Mfg by: Dr. Reddy's Laboratories Limited, FTO-SEZ, Process Unit-01 Devunipalavalasa Village Srikakulam (District) Andhra Pradesh, INDIA. Manufactured for: EPI Health, LLC 134 Columbus St. Charleston, SC 29403 USA. NDC 71403-102-05. Failed Dissolution Specifications: 71403-101-05, 71403-102-05, 71403-101-30, 71403-102-30 20191002 Lot# T900093, Exp 11/2020 1,626 5-count bottles
Johnson Matthey Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001, NDC 49821-0075-XX cGMP Deviations: Potential glass contamination 20191002 Lot #: B0126-170701; B0126-170802; Exp. Sep 2022; B0126-180401, Exp. May 2023; B0126-180702, B0126-180803, Exp. Oct 2023 316703.32
Aurolife Pharma Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648; Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810. Failed Impurities/Degradation Specifications 20190925 Lot #s:067180011A, 067180012A, Exp 04/21, 06718027B1, Exp 09/21 6104 bottles
Aurolife Pharma Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug mart FOOD FAIR, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256, NDC 53943-021-09. Failed Impurities/Degradation Specifications 53943-021-60, 53943-021-85, 53943-021-17, 53943-021-09 20190925 Lot #: 067180024B1, Exp 07/21 4536 cartons
Torrent Pharma Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10 CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million. 13668-115-30, 13668-409-90, 13668-409-74, 13668-113-74, 13668-115-74, 13668-113-90, 13668-409-10, 13668-115-10, 13668-409-30, 13668-113-10, 13668-115-90 20191009 Lot 4DU2E009 8,688 bottles
Torrent Pharma Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10 CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million. 13668-115-30, 13668-409-90, 13668-409-74, 13668-113-74, 13668-115-74, 13668-113-90, 13668-409-10, 13668-115-10, 13668-409-30, 13668-113-10, 13668-115-90 20191009 Count, lot, expiry: [90 count] Lot 4DU3E009, exp 12/31/2020; [1000 count] Lot 4DU3D018, exp 02/28/2021 39,432 bottles
Sandoz, Inc Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31 CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA). 0781-1884-31, 0781-1883-60, 0781-2865-05, 0781-2855-31, 0781-2865-92, 0781-1883-05, 0781-2855-05, 0781-1883-10, 0781-1883-01, 0781-2855-92, 0781-2855-60, 0781-1884-25, 0781-1884-10, 0781-2865-31 20191016 HD8625 4/30/2020 HD9275 4/30/2020 HU2207 8/31/2020 HX6676 3/31/2021 HX6677 3/31/2021 136,788 bottles
Sandoz, Inc Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05 CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA). 0781-1884-31, 0781-1883-60, 0781-2865-05, 0781-2855-31, 0781-2865-92, 0781-1883-05, 0781-2855-05, 0781-1883-10, 0781-1883-01, 0781-2855-92, 0781-2855-60, 0781-1884-25, 0781-1884-10, 0781-2865-31 20191016 HD1862 4/30/2020 HP9438 9/30/2020 HP9439 9/30/2020 HP9440 9/30/2020 13,130 bottles
GUERBET LLC Optiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine, packaged in 1 - 100 mL Ultraject Prefilled Syringe For Power Injection per carton, RFID Technology, Rx Only, Manufactured by: Liebel-Flarshelm Company, LLC., Raleigh, NC 27616; NDC 0019-1323-00. Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector. 0019-1333-55, 0019-1323-16, 0019-1332-06, 0019-1323-11, 0019-1333-78, 0019-1333-77, 0019-1324-87, 0019-1333-75, 0019-1332-21, 0019-1324-81, 0019-1332-83, 0019-1323-95, 0019-1323-90, 0019-1323-91, 0019-1332-75, 0019-1332-00, 0019-1333-87, 0019-1333-85, 0019-1333-83, 0019-1333-81, 0019-1333-52, 0019-1324-11, 0019-1332-90, 0019-1332-91, 0019-1333-06, 0019-1323-06, 0019-1323-21, 0019-1333-00, 0019-1333-21, 0019-1324-75, 0019-1323-04, 0019-1323-02, 0019-1333-27, 0019-1332-78, 0019-1332-11, 0019-1332-16, 0019-1324-78, 0019-1323-87, 0019-1323-85, 0019-1323-83, 0019-1323-27, 0019-1323-81, 0019-1333-91, 0019-1333-90, 0019-1333-95, 0019-1323-00, 0019-1324-06, 0019-1323-77, 0019-1323-75, 0019-1323-73, 0019-1323-70, 0019-1333-11, 0019-1324-21, 0019-1323-52, 0019-1324-27, 0019-1323-55, 0019-1323-78, 0019-1333-16 20191016 Lots: L141C, L162A Exp. 06/2021; L146DS, Exp. 05/2021 3860 syringes
KRS Global Biot Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.25 mg / 0.25 mL, 0.25 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678126 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 1290 syringes
KRS Global Biot Human Chorionic Gonadotropin 11,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673974 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 6620 vials
KRS Global Biot fentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487 NDC 33216286000 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 1882 bags
Colonia Care Ph C-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 071819E, BUD 09/01/19 1 droptainer bottle
KRS Global Biot Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677749 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 317 vials
KRS Global Biot PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites). 30 mg/250 mL (0.12 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678401 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 60 bags
KRS Global Biot Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL), 50 mL Fill in a 60 mL Single Dose Syringe, For IV Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674199 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 540 syringes
KRS Global Biot NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 4 mg/250 mL (0.016 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487, NDC 3321678032 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 528 bags
Colonia Care Ph C-CALCIUM GLUCNATE 1% INJECTION SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 071119C, BUD 08/25/19 1 vial
KRS Global Biot Sermorelin Acetate, 3 mg/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL Injections-CART-Item#: 73752, For SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 218 cartridges
KRS Global Biot Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL) / Ketorolac Tromethamine 0.5% (2.5 mg/0.5 mL), Sterile Ophthalmic Topical Solution, 0.5 mL Fill in 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677510 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 1815 syringes
KRS Global Biot GLYCOpyrrolate (PF) 1 mg/5 mL (0.2 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC03321678317 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 2625 syringes
Colonia Care Ph C-MB12 NAC 13MG/48MG/ML INJ SOLN, 0.29 mL in a 0.3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 070919C, BUD 08/23/19 15 syringes
KRS Global Biot PHENYLephrine HCl 1.5% (15 mg/mL) LIDOcaine 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL fill in a 5 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678170 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 3150 vials
KRS Global Biot Vitamin 10 B Lyophilized, Vial, For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678338 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 6747 vials
KRS Global Biot Methylcobalamin 30 mL Vial-For SC / IM / IV Use, 30 mg / 30 mL (1 mg / mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674232 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 1189 vials
KRS Global Biot Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine Mesylate-15 mg / Atropine Sulfate Monohydrate-1.5 mg/vial), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678383 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 95 vials
Colonia Care Ph C-PAPAV/PHENTOL/PGE1 30MG/0.5MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 072219A, BUD 09/05/19 1 vial
Colonia Care Ph C-HYDROXOCOBALAMIN 25 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 070919E, BUD 08/23/19 15 syringes
Colonia Care Ph C-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL in 60 nebulizer vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 070219B, BUD 08/06/19 60 nebulizer vials
KRS Global Biot Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678441 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 825 syringe
KRS Global Biot Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678334 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 345 vials
Colonia Care Ph C-ATROPINE SULF OPHTH 0.02%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 071619D, BUD 08/30/19 1 droptainer bottles
Colonia Care Ph C-TACROLIMUS 0.03% OPHTHAL SUSPENSION, 5 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 071019B, BUD 08/09/19 1 droptainer bottle
KRS Global Biot OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units / mL) Single Dose IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676819 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 4497 bags
Colonia Care Ph C-METHYLCOBALAMIN 25MG/ML INJECTION PFS, packaged in 0.3 mL, 0.5 mL, 1 mL, and 3 mL syringes, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 020719A, BUD 08/06/19; 051619E, BUD 11/12/19 191 syringes
Cardinal Health Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For subcutaneous use only, Rx Only, Manufactured by GlaxoSmithKline LLC, Philadelphia, PA 19112, Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0892-42. Temperature Abuse; Product stored and shipped outside of labeled storage requirements. 0173-0892-01, 0173-0881-01, 0173-0892-42, 0173-0892-61, 0173-0881-61, 0173-0892-63 20191002 Lot #: S25X, Exp. 03/31/21 38 syringes
Shire Human Gen Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0203-02 Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing 20191002 06628461, exp 8/31/2020 06661658, 07110136, 7164106, 07761970 exp 10/31/2020 07630717, 08689119, exp 12/31/2020 07769458, exp 4/30/2021 07983643, 08003758, exp 6/30/2021 08214790, exp 8/31/2020 NY17002DA, NY17002DB, exp 6/30/2020 13,897
Colonia Care Ph C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 062419B, BUD 08/08/19 1 vial
KRS Global Biot fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216282300 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 492 bags
Aurolife Pharma Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0097-55. Failed Impurities/Degradation Specifications 0363-0095-24, 0363-0097-55, 0363-0097-53 20190925 Lot #: 06718027A1, Exp 09/21 4920 cartons
Ridge Propertie PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Cream, 4%, packaged in a) 1 OZ (NDC 69804-002-05), b) 2 OZ (NDC 69804-002-02), and c) 4 OZ (NDC 69804-002-03) jars, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301. Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay. 69804-002-05, 69804-002-03, 69804-002-02 20190925 Lot # 1222, Exp 06/14/2023 383.65 ounces total
Aurolife Pharma Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton, Good Neighbor Pharmacy, Distributed By Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-387-23. Failed Impurities/Degradation Specifications 46122-387-23 20190925 Lot #: 067180024A1, Exp 07/21 3240 cartons
Preferred Pharm Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by Preferred Pharmaceuticals, Inc., Anaheim, CA, NDC #: 68788-6848-09 Failed Impurities/Degradation Specifications 20191002 Lot #: G0219K, Exp 3/2021; C1419E, Exp 3/2021 79 (90 ct.) bottles
Shire Human Gen Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA 68875-0205-02 Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing 20191002 06828752, exp 12/31/2019 07110118, exp 4/30/2021 07164107, exp 12/31/2019 07200436, 07301074, exp 4/30/2021 07482212, 07630715, exp 6/30/2021 07769460, exp 4/30/2021 8,003
West-Ward Colum Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, Distr. by: West-Ward Pharmaceuticals,Eatontown, NJ. NDC:0054-0199-59 Failed Impurities/Degradation Specificattion 0054-0199-59 20190925 Lot, expiry: Lots AA3957A, AA3958A, exp May 2020; Lot AA5164A, exp Sep 2020 32,347 bottles
KRS Global Biot Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676500 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 162 vials
KRS Global Biot L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674499 Lack of Assurance of Sterility 20191009 All lots remaining within expiry.
Colonia Care Ph C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 072219B, BUD 08/05/19 1 droptainer vial
KRS Global Biot GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678316 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 10630 syringes
KRS Global Biot LIDOcaine HCl 2% (PF) 100 mg/5 mL (20 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487NDC 3321678315 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 4450 syringes
KRS Global Biot Quadmix #13A (Prostaglandin E1-0.3 mg / Papaverine HCl-200 mg / Phentolamine Mesylate-30 mg / Atropine Sulfate Monohydrate-0.375 mg / Vial) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678398 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 91 vials
Akorn, Inc. Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15. Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product. 17478-201-15, 17478-206-05, 17478-201-02 20191009 Lot #: 031908A, Exp 03/20 60,176 bottles
KRS Global Biot NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677847 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 7685 syringes
KRS Global Biot L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676396 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 6447 vials
KRS Global Biot Human Chorionic Gonadotropin 5,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC03321673964 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 2219 vials
Colonia Care Ph C-UREA 40% BLADDER INSTILL, 30 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 062719A, BUD 08/11/19 7 vials
KRS Global Biot NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678303 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 3410 syringes
Shire Human Gen Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0204-02 Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing 20191002 06628462, exp 5/31/2020 06651000, exp 9/30/2020 06661659, exp 6/30/2020 07110125, 07301073, exp 10/31/2020 07200435, 7/31/2020 07482211, exp 12/31/2020 07630714, exp 3/31/2021 NX170002DA, exp 12/31/2019 NX17004DA, exp 3/31/2020 NX17007DA, NX17007DB, NX17008DA exp 4/30/2020 NX17010DA, NX17012DA, exp 6/30/2020 15,075
Ridge Propertie PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-019-14), b) 2 Oz (NDC 69804-019-15), and c) 4 Oz (NDC 69804-019-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301. Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay. 69804-019-16, 69804-019-14, 69804-019-15 20190925 Lot # 1213, Exp 06/05/2023 109.64 ounces total
Aurolife Pharma Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648, NDC 58602-711-21 Failed Impurities/Degradation Specifications 58602-711-19, 58602-710-40, 58602-710-75, 58602-711-21 20190925 Lot #: 067180008A, Exp 03/21 8,240 bottles
GCP Laboratorie Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle, Distributed by: Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA. NDC 0904-5894-30 Microbial Contamination of Non-Sterile Product. 0904-5894-30 20191016 Lot: WBD003 Exp. 03/21 31,392 30 mL bottles
KRS Global Biot ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 25 mg/5 mL (5 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678374 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 12445 syringes
Colonia Care Ph C-HYDROXOCOBALAMIN 5 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 062619E, BUD 08/10/19 30 syringe
Alkermes, Inc. Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 mg of Vivitrol, 2) One vial containing 4 mL of diluent, 3) One 5-mL prepackaged syringe, 4) One 20-gauge 1-inch needle, 5) Two 20-gauge 1.5-inch safety needles, 6) Two 20-gauge 2-inch safety needles. Rx Only. Manufactured and marketed by: Alkermes, Inc. Kit NDC: 65757-300-01 Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted. 65757-300-01, 65757-304-03, 65757-302-02 20191009 Lot 2019-1002T, 2019-1003T, Exp 05/2021 16,231 kits
Colonia Care Ph C-MB12/HB12 5MG/5MG/ML INJ SOLN, 0.9 mL in a 3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 071819C, BUD 09/01/19 6 syringes
KRS Global Biot Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674092 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 120 vials
Colonia Care Ph C-PAPAV/PHENTOL/PGE1 30MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 071819H, BUD 09/01/19 1 vial
KRS Global Biot Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674205 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 77 vials
KRS Global Biot Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673589 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 246 vials
KRS Global Biot Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321601122 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 64 vials
KRS Global Biot Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 3 mL Fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678359 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 928 vials
KRS Global Biot Human Chorionic Gonadotropin 20,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673977 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 1871 vials
Colonia Care Ph C-GENTAMICIN 30MG/ML INJ SOLUTION SDV, 3 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 070319J, BUD 08/17/19 1 vial
Pfizer Inc. ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by: Greenstone LLC Peapack, NJ 07977 Made in Netherlands. NDC 59762-2250-2 Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020. 59762-2250-2 20191002 Lot #3267079A, Exp 09/2021 7,824 100-count bottles
Ridge Propertie Superior Pain & Itch Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-070-05), b) 2 OZ (NDC 69804-070-02), and c) 4 OZ (NDC 69804-070-03) jars, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301. Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay. 69804-070-05, 69804-070-02, 69804-070-03 20190925 Lot # 1222, Exp 06/14/2023 383.65 ounces total
Aurolife Pharma Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 62011-0315-1); and b) 30-count cartons (NDC 62011-0315-2) HealthMart PHARMACY, Distributed by McKesson, One Post Street, San Francisco, CA 94104. Failed Impurities/Degradation Specifications 20190925 Lot #s: a) 067180010B, Exp 03/21; 067180024E1, Exp 07/21; b) 067180016A, Exp 05/21 a) 10,992 cartons; b) 24,792 cartons
Torrent Pharma Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-453-01. Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing. 13668-453-30, 13668-462-01, 13668-453-74, 13668-453-01, 13668-462-30, 13668-462-74 20190925 Lot #: BFE2E003, Exp 08/31/2020 2472 bottles
Teva Pharmaceut Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, Rx only, Manufactured by: Actabis Laboratories FL, Inc., Fort Lauderdale, FL, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 52544-692-30 GMP Deviation: lot not intended for commercial distribution. 52544-691-19, 52544-692-19, 52544-692-30, 52544-693-10, 52544-692-10, 52544-691-10, 52544-694-19, 52544-693-19, 52544-695-10, 52544-694-30, 52544-695-30, 52544-691-30, 52544-695-19, 52544-694-10, 52544-693-30 20191016 Lot # 1344864A, exp. date 10/2020 5,849 bottles
Amneal Pharmace Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10 Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle 65162-751-50, 65162-752-50, 65162-754-50, 65162-751-03, 65162-753-50, 65162-754-10, 65162-751-10, 65162-752-10, 65162-752-03, 65162-754-03, 65162-753-03, 65162-753-10 20191016 Lot # BB02619A, exp. date 04/2021 9,720 100 count bottles
Epic Pharma, LL Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-087-01 Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets. 42806-087-05, 42806-088-01, 42806-089-05, 42806-087-01, 42806-088-05, 42806-089-01, 42806-089-09 20191016 Lot #: 19094A, Exp. 2021 11,472 (bottles of 100)
KRS Global Biot ePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg/5 mL (10 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe. KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678375 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 3895 syringes
KRS Global Biot L-Carnitine 27 mL in a 30 mL Vial, 4,590 mg/27 mL (170 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674166 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 10014 vials
KRS Global Biot Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxine HCl 1,500 mg / Cyanocobalamin 30 mg Lyophilized, Vial For IM Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321675952 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 497 vials
KRS Global Biot Ketamine in 0.9% Sodium Chloride (PF) 10 mg/mL, 1 mL fill in a 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216077967 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 1044 syringes
GUERBET LLC Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefilled Syringe For Power Injection per carton, RFID Technology, Rx Only, Manufactured by: Liebel-Flarshelm Company, LLC., Raleigh, NC 27616; NDC 0019-1188-27. Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector. 0019-1188-27, 0019-1188-81 20191016 Lots: L159A, Exp. 06/2021; L169A, Exp. 07/2021 3140 syringes
KRS Global Biot PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 25 mg / 250 mL (0.1 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677861 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 708 bags
KRS Global Biot Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678217 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 2760 bags
KRS Global Biot Nicotinamide Adenine Dinucleotide (PF), Lyophilized-For IV Use-Single Dose Vial, 500 mg/Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678103 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 4390 vials
KRS Global Biot Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer,Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676223 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 242 droptainers
KRS Global Biot LIDOcaine HCl 0.75%(7.5 mg/mL)/ EPINRPHrine 0.025% (0.25 mg/mL) (PF) (Sulfite Free) in BSS, 1 mL Fill in a 3 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678395 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 4105 syringes
Colonia Care Ph C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/11.8MCG/ML, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 062719E, BUD 08/11/19 1 vial
Colonia Care Ph C-PAPAV/PHENTOL/PGE1 10MG/1MG/10MCG/ML, packaged in a) 5 mL and b) 10 mL vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: a) and b) 071119E, BUD 08/25/19 6 vials
KRS Global Biot NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678406 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 1464 bags
KRS Global Biot fentaNYL Citrate in 0.9% Sodium Chloride (PF), 2,000 mcg/100 mL (20 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216286300 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 934 bags
Colonia Care Ph C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: a) 070819A, BUD 08/22/19; b) 071619F, BUD 08/30/19 2 droptainer bottles
Ridge Propertie Soothing Sore Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-074-05), b) 2 OZ (NDC 69804-074-02), and c) 4 OZ (NDC 69804-074-03) jars, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301. Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay. 69804-074-02, 69804-074-03, 69804-074-05 20190925 Lot # 1228, Exp 06/21/2023 136 ounces
Aurolife Pharma fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, Distributed by: Sam's West, Inc., Bentonville, AR 22716, NDC 68196-976-91, UPC 0 78742 23550 9. Failed Impurities/Degradation Specifications 68196-976-91 20190925 Lot #'s: 067180009A, Exp 03/21; 067180013A, 067180014A, 067180015A, Exp 04/21; 067180018A, Exp 05/21; 067180020A, Exp 06/21; 067180021A1, 067180022A1, Exp 07/21; 06718028A1, 06718028B1, Exp 09/21; 06719001A3, Exp 01/22 71,748 bottles
KRS Global Biot Sermorelin, 3 mg/GHRP6, 3 mg/GHRP2, 3 mg/Vial, For SC Use, Vial-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673816 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 647 vials
KRS Global Biot Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321674186 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 402 vials
KRS Global Biot Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), 3 mL Droptainer, Sterile Ophthalmic Topical Solution, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676225 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 649 droptainers
Colonia Care Ph C-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 070119A, BUD 08/15/19; 072219N, BUD 09/05/19 12 droptainer bottles
KRS Global Biot Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673588 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 341 vials
KRS Global Biot Vitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678341 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 508 vials
KRS Global Biot Ascorbic Acid (Tapioca Source) (PF) 25 g/50 mL (0.5 g/mL) 50 mL Vial-Single Dose Only-For IV/SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487 NDC 3321675412 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 2219 vials
Akorn, Inc. Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30 cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line. 17478-711-31, 17478-711-30, 17478-711-10 20191002 Lot #: 9B21A, Exp. 1/2022 10,543 tubes
Ridge Propertie Soothing Sore Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-077-14), b) 2 Oz (NDC 69804-077-15), and c) 4 Oz (NDC 69804-077-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301. Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay. 69804-077-16, 69804-077-14, 69804-077-15 20190925 Lot # 1135, Exp 12/27/2022 104.1 ounces
Aurolife Pharma Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton (NDC 70677-0008-1), sunmark, Distributed by McKesson, One Post Street, San Francisco, CA 94104. Failed Impurities/Degradation Specifications 20190925 Lot #s: a) 067180016B, Exp 05/21 and b) 067180024F1, Exp 07/21 a) 11,928 cartons; b) 288 cartons
Mylan Laborator Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60. Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product. 67457-445-60 20191016 Lot: 7008334, Exp April 2020; 7008417, Exp Oct 2020 19,165 vials
Pfizer Inc. 10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7418-13 Lack of Assurance of Sterility: Bag has the potential to leak. 0409-7418-13, 0409-7419-14, 0409-7418-03, 0409-7419-03 20191016 Lot #: 87-095-JT Exp. 1MAR2020 17832 bags
KRS Global Biot Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 152 cartridges
KRS Global Biot Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.3 mg/0.3 mL, 0.3 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678320 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 9920 syringes
KRS Global Biot Hydroxocobalamin 10 mg/20 mL (0.5 mg/mL) 20 mL fill in a 30 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678337 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 345 vials
KRS Global Biot Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Catheter Use Only, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676603 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 150 vials
Colonia Care Ph C-VERAPAMIL 2.5MG/ML INJ SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 072319A, BUD 09/06/19 1 vial
KRS Global Biot Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678335 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 948 vials
Colonia Care Ph C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 062419C, BUD 08/08/19 1 vial
KRS Global Biot Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676419 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 6405 syringes
KRS Global Biot Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Single Dose Only, Contains Sulfites, For Slow IV use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677610 Lack of Assurance of Sterility 20191009 All lots remaining within expiry.
KRS Global Biot Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674177 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 6568 vials
KRS Global Biot Magnesium Chloride Hexahydrate 82.5 mg/mL; Calcium Gluconate 30 mg/mL (PF), For IV Use, 10 mL Single Dose vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678355 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 878 vials
Colonia Care Ph C-PHENOL/COTTONSEED OIL INJ 5%, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 070319F, BUD 08/17/19 1 vial
Unipharma, Llc. DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-Use Vials a) 0.5 mL Each (20 count) UPC 37030244608; b) 1.5 mL Each (20 count) UPC 370302446098, Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321 CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. 20191016 Lot: 80003 Exp. 01/31/20; 70003 Exp. 10/31/19; 70005 Exp. 11/30/19; 70006 Exp. 11/30/19 456 cartons
KRS Global Biot LIDOcaine HCl 1% (PF) 50 mg/5 mL (10 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678424 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 2565 syringes
KRS Global Biot Vitamin 9 Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674147 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 470 vials
KRS Global Biot SUCCinylcholine Chloride (PF), 100 mg / 5 mL (20 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, For IV Use-Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678418 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 7905 syringes
KRS Global Biot Vitamin 5 B, 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674253 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 616 vials
KRS Global Biot LIDOcaine 2% (20 mg/mL)/Bupivacaine 0.375% (3.75 mg/mL)/ Hyaluronidase 3 U/mL (PF) Ophthalmic Injection, 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678362 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 2255 syringes
KRS Global Biot Lidocaine HCl 30 mg/mL/Hyaluronidase 15 Units/mL (PF) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678368 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 2615 syringes
Colonia Care Ph C-PAPAV/PHENTOL/PGE1 20MG/2MG/20MCG/ML, packaged in a) 5 mL and b) 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: a) and b) 070519A, BUD 08/19/19 7 vials
KRS Global Biot SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678417 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 1350 syringes
Colonia Care Ph C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION, 3 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 070819B, BUD 08/07/19 1 droptainer bottle
KRS Global Biot PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 250 mL (0.4 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678039 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 228 bags
Colonia Care Ph C-PAPAV/PHENTOL/PGE1 10MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 071619J, BUD 08/30/19 1 vial
KRS Global Biot ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 50 mg/10 mL (5 mg/mL) 10 mL Fill in a 12 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678373 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 16585 syringes
Colonia Care Ph C-DEXAMETHASONE 24MG/ML INJ SOLUTION, packaged in 1 mL single dose vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 070319G, BUD 08/17/19; 071219P, BUD 08/26/19 37 vials
Johnson Matthey Cisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001 cGMP Deviations: Potential glass contamination 20191002 Lot #: B0101-161102, Exp. Dec 2021 26625 grams
Johnson Matthey Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001. cGMP Deviations: Potential glass contamination 20191002 Lot #: B0030-180101, B0030-180102, Exp. Feb 2023 52882.23 grams
Aurolife Pharma Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, Distributed by: Aurohealth LLC, 2572 Brunswick Pike, Lawrenceville, NJ 08648; NDC 58602-820-09. Failed Impurities/Degradation Specifications 20190925 Lot #: 067180026A1, Exp 07/21 240 bottles
Ridge Propertie Superior Pain & Itch Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-073-14), b) 2 Oz (NDC 69804-073-15), and c) 4 Oz (NDC 69804-073-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301. Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay. 69804-073-16, 69804-073-14, 69804-073-15 20190925 Lot # 1213, Exp 06/05/2023 109.64 ounces total
Morton Grove Ph Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053. NDC 60432-212-08 Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14 60432-212-08 20191016 Lot #: US1450, Exp 10/31/19; US1570, Exp 12/31/19; UT1018, Exp 1/31/19; UT1173, Exp 6/30/20; UT1348, UT1354, Exp 8/31/20 196,408 bottles
Colonia Care Ph C-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 041119A, BUD 10/08/19; 051019J, BUD 11/6/19; 070519C, BUD 01/01/20 18 vials
Colonia Care Ph C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 072419B, BUD 09/07/19 1 vial
Colonia Care Ph C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.8MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 072419C, BUD 09/07/19; 071519D, BUD 08/29/19 2 vials
KRS Global Biot SUCCinylcholine Chloride (PF), 200 mg/10 mL (20 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678416 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 3820 syringes
KRS Global Biot Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678092 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 242 droptainers
Colonia Care Ph C-PAPAV/PHENTOL/PGE1 30MG/2MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 Lack of Assurance of Sterility: product sterility cannot be guaranteed. 20191009 Lot #: 070319A, BUD 08/17/19 1 vial
KRS Global Biot Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673969 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 2263 vials
KRS Global Biot Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678339 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 6325 vials
KRS Global Biot Sermorelin Acetate, 9 mg / GHRP-2, 5.4 mg/vial Lyophilized-for SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674047 Lack of Assurance of Sterility 20191009 All lots remaining within expiry. 258 vials
Shire Human Gen Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0202-02 Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing 20191002 08569357, exp 4/30/2020; 07983652, 08544833, exp 6/30/2021 1,556
Aurolife Pharma Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-995-62. Failed Impurities/Degradation Specifications 49035-995-62, 49035-995-60 20190925 Lot #s: 067180010A, Exp 03/21; 067180023C1, 067180024D1, Exp 07/21 129,600 cartons
Aurolife Pharma Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 60000-409-53); b) 30-count cartons (NDC 60000-409-30); c) 45-count bonus cartons (NDC 60000-409-48); d) 45-count cartons (NDC 60000-409-45); CAREone, Distributed by: Foodhold U.S.A., LLC, Landover, MD 20785. Failed Impurities/Degradation Specifications 60000-409-30, 60000-409-53, 60000-409-45, 60000-409-48 20190925 Lot #s: a) 067180025D1, Exp 07/21; b) 067180025B1, Exp 07/21; c) 067180025A1, Exp 07/21; d) 067180025C1, Exp 07/21 a) 9662 cartons; b) 7382 cartons; c) 5184 cartons; d) 9842 cartons

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