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Consolidated Pharma Data Platform, see what is new over the past 30 days.

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.

8 FDA CDER quality inspections posted in last 60 days

This is updated weekly with the latest FDA inspections.

Company City Country Inspection End Date Project Area Classification
Yichang Humanwell Or Yichang CN 2019-06-28 Drug Quality Assurance VAI
Regenesis Pharmaceut Santa Ana US 2019-06-18 Drug Quality Assurance VAI
Sunrider Manufacturi Torrance US 2019-07-03 Drug Quality Assurance VAI
Unchained Labs Pleasanton US 2019-06-18 Drug Quality Assurance NAI
Apotex Inc. North York CA 2019-06-19 Drug Quality Assurance NAI
General Cryogenic Te Westbury US 2019-06-20 Drug Quality Assurance NAI
Private Label Skin C Chatsworth US 2019-06-28 Drug Quality Assurance NAI
RTI Services Inc (Ka Independence US 2019-07-08 Drug Quality Assurance NAI

WIZMED searches for the latest public 483s weekly.

MFG Country Date Link
Dr. Reddy's Laboratories Ltd. Unit II India 2019-07-12
Cipla Ltd. Virgonagar Site India 2019-07-19
Dr. Reddy's Laboratories Ltd. India 2019-06-21

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

Company Issue Date Office Link
Verdict Vapors, LLC 2019-07-31 Center for Tobacco Products
Med Shop Total Care 2019-07-30 Office of Pharmaceutical Quality Operations, Division II
U.F.S. Industries, I 2019-07-30 Division of Human and Animal Food Operations East I
Results RNA, LLC 2019-07-29 Division of Pharmaceutical Quality Operations IV
Premium Production L 2019-07-29 Division of Human and Animal Food Operations West IV
Sinu Co., Ltd 2019-07-24 Center for Food Safety and Applied Nutrition
V8P Juice Internatio 2019-08-08 Center for Tobacco Products
Liquid Labs USA, LLC 2019-08-08 Center for Tobacco Products
Mighty Vapors, LLC, 2019-08-08 Center for Tobacco Products
Hookah Imports Inc 2019-08-08 Center for Tobacco Products
Curaleaf, Inc 2019-07-22 Center for Drug Evaluation and Research

Monitor latest FDA approvals

MFG Route Drug Strength NDCs Type Approval Date PI Labels
Ascend Laborato oral pregabalin 20 mg/mL 67877-457-47 ANDA 2019-07-21
Ascend Laborato oral pregabalin 300 mg/1 67877-469-33, 67877-469-38, 67877-469-05, 67877-469-30, 67877-469-90 ANDA 2019-07-21
Ascend Laborato oral pregabalin 225 mg/1 67877-468-90, 67877-468-38, 67877-468-05, 67877-468-33, 67877-468-30 ANDA 2019-07-21
Ascend Laborato oral dexmethylphenidate hydrochloride 2.5 mg/1 67877-655-30, 67877-655-05, 67877-655-01 ANDA 2019-07-21
Ascend Laborato oral pregabalin 150 mg/1 67877-466-05, 67877-466-30, 67877-466-33, 67877-466-38, 67877-466-90 ANDA 2019-07-21
Ascend Laborato oral dexmethylphenidate hydrochloride 10 mg/1 67877-657-30, 67877-657-05, 67877-657-01 ANDA 2019-07-21
Ascend Laborato oral pregabalin 100 mg/1 67877-465-90, 67877-465-05, 67877-465-30, 67877-465-33, 67877-465-38 ANDA 2019-07-21
Ascend Laborato oral pregabalin 75 mg/1 67877-464-33, 67877-464-30, 67877-464-05, 67877-464-90, 67877-464-38 ANDA 2019-07-21
Ascend Laborato oral dexmethylphenidate hydrochloride 5 mg/1 67877-656-30, 67877-656-05, 67877-656-01 ANDA 2019-07-21
Ascend Laborato oral pregabalin 200 mg/1 67877-467-30, 67877-467-05, 67877-467-38, 67877-467-33, 67877-467-90 ANDA 2019-07-21
Cipla USA, Inc. oral pregabalin 300 mg/1 69097-962-05 ANDA 2019-07-19
Cipla USA, Inc. oral pregabalin 200 mg/1 69097-959-05 ANDA 2019-07-19
Cipla USA, Inc. oral pregabalin 150 mg/1 69097-958-12, 69097-958-05 ANDA 2019-07-19
Cipla USA, Inc. oral pregabalin 100 mg/1 69097-957-12, 69097-957-05 ANDA 2019-07-19
Cipla USA, Inc. oral pregabalin 225 mg/1 69097-961-05 ANDA 2019-07-19
Cipla USA, Inc. oral pregabalin 75 mg/1 69097-956-12, 69097-956-05 ANDA 2019-07-19
Cipla USA, Inc. oral pregabalin 25 mg/1 69097-954-12, 69097-954-05 ANDA 2019-07-19
Cipla USA, Inc. oral pregabalin 50 mg/1 69097-955-05, 69097-955-12 ANDA 2019-07-19
Amneal Pharmace oral pregabalin 50 mg/1 69238-1311-9 ANDA 2019-07-19
Amneal Pharmace oral pregabalin 200 mg/1 69238-1315-9 ANDA 2019-07-19
Amneal Pharmace oral pregabalin 75 mg/1 69238-1312-9 ANDA 2019-07-19
Amneal Pharmace oral pregabalin 150 mg/1 69238-1314-9 ANDA 2019-07-19
Amneal Pharmace oral pregabalin 100 mg/1 69238-1313-9 ANDA 2019-07-19
Amneal Pharmace oral pregabalin 25 mg/1 69238-1310-9 ANDA 2019-07-19
Amneal Pharmace oral pregabalin 225 mg/1 69238-1316-9 ANDA 2019-07-19
Amneal Pharmace oral pregabalin 300 mg/1 69238-1317-9 ANDA 2019-07-19
MSN LABORATORIE oral pregabalin 300 mg/1 69539-018-05, 69539-018-06, 69539-018-90 ANDA 2019-07-19
MSN LABORATORIE oral pregabalin 75 mg/1 69539-013-06, 69539-013-99, 69539-013-90 ANDA 2019-07-19
MSN LABORATORIE oral pregabalin 150 mg/1 69539-015-90, 69539-015-06, 69539-015-05 ANDA 2019-07-19
MSN LABORATORIE oral pregabalin 225 mg/1 69539-017-06, 69539-017-90, 69539-017-99 ANDA 2019-07-19
MSN LABORATORIE oral pregabalin 200 mg/1 69539-016-90, 69539-016-06, 69539-016-99 ANDA 2019-07-19
MSN LABORATORIE oral pregabalin 50 mg/1 69539-012-99, 69539-012-90, 69539-012-06 ANDA 2019-07-19
MSN LABORATORIE oral pregabalin 100 mg/1 69539-014-90, 69539-014-06, 69539-014-99 ANDA 2019-07-19
MSN LABORATORIE oral pregabalin 25 mg/1 69539-011-06, 69539-011-99, 69539-011-90 ANDA 2019-07-19
Somerset Therap subcutaneous isosulfan blue 10 mg/mL 70069-221-06 ANDA 2019-07-23
Vi Medical Prod topical hydroquinone 4 g/100mL 70484-101-12 UNAPPROVED DRUG OTHER 2019-07-28
MAIA Pharmaceut intravenous bivalirudin 250 mg/1 70511-141-84, 70511-141-50 NDA 2019-08-08
Cadila Healthca oral ramelteon 8 mg/1 70771-1495-5, 70771-1495-3, 70771-1495-1 ANDA 2019-07-23
Zydus Pharmaceu oral ramelteon 8 mg/1 70710-1344-1, 70710-1344-3, 70710-1344-5 ANDA 2019-07-23
Novadoz Pharmac oral pregabalin 75 mg/1 72205-013-90, 72205-013-99, 72205-013-06 ANDA 2019-07-19
Novadoz Pharmac oral pregabalin 150 mg/1 72205-015-06, 72205-015-90, 72205-015-05 ANDA 2019-07-19
Novadoz Pharmac oral pregabalin 225 mg/1 72205-017-06, 72205-017-99, 72205-017-90 ANDA 2019-07-19
Tasman Pharma I topical clotrimazole topical solution usp, 1% 10 mg/mL 72641-001-30 ANDA 2019-07-25
Direct_Rx oral pregabalin 100 mg/1 72189-023-60 ANDA 2019-08-02
Novadoz Pharmac oral pregabalin 50 mg/1 72205-012-99, 72205-012-06, 72205-012-90 ANDA 2019-07-19
Direct_Rx oral pregabalin 50 mg/1 72189-019-30 ANDA 2019-07-31
Novadoz Pharmac oral pregabalin 100 mg/1 72205-014-99, 72205-014-06, 72205-014-90 ANDA 2019-07-19
Novadoz Pharmac oral pregabalin 25 mg/1 72205-011-99, 72205-011-90, 72205-011-06 ANDA 2019-07-19
Direct_Rx oral pregabalin 150 mg/1 72189-020-60 ANDA 2019-07-31
Direct_Rx oral pregabalin 75 mg/1 72189-021-90 ANDA 2019-07-30
Direct_Rx oral pregabalin 50 mg/1 72189-019-60 ANDA 2019-07-31
Direct_Rx oral pregabalin 100 mg/1 72189-023-90 ANDA 2019-08-02
Direct_Rx oral pregabalin 100 mg/1 72189-023-30 ANDA 2019-08-02
Novadoz Pharmac oral pregabalin 300 mg/1 72205-018-90, 72205-018-06, 72205-018-05 ANDA 2019-07-19
Novadoz Pharmac oral pregabalin 200 mg/1 72205-016-90, 72205-016-06, 72205-016-99 ANDA 2019-07-19
Direct_Rx oral pregabalin 50 mg/1 72189-019-90 ANDA 2019-07-31
Direct_Rx oral pregabalin 150 mg/1 72189-020-90 ANDA 2019-07-31
Direct_Rx oral pregabalin 150 mg/1 72189-020-30 ANDA 2019-07-31
Exelan Pharmace oral pregabalin 25 mg/1 76282-568-90, 76282-568-05 ANDA 2019-07-19
Lacer Pharma, L topical benzoyl peroxide 9.8 g/g 73159-001-01 UNAPPROVED DRUG OTHER 2019-07-25
Exelan Pharmace oral pregabalin 300 mg/1 76282-575-90, 76282-575-05 ANDA 2019-07-19
Laboratorio Rei intravenous piperacillin and tazobactam 4 g/20mL, .5 g/20mL 76233-278-20 ANDA 2019-07-25
Exelan Pharmace oral pregabalin 150 mg/1 76282-572-05, 76282-572-90 ANDA 2019-07-19
Exelan Pharmace oral pregabalin 50 mg/1 76282-569-05, 76282-569-90 ANDA 2019-07-19
Laboratorio Rei intravenous piperacillin and tazobactam 2 g/10mL, .25 g/10mL 76233-279-20 ANDA 2019-07-25
Exelan Pharmace oral pregabalin 200 mg/1 76282-573-05, 76282-573-90 ANDA 2019-07-19
Exelan Pharmace oral pregabalin 75 mg/1 76282-570-05, 76282-570-90 ANDA 2019-07-19
Exelan Pharmace oral pregabalin 100 mg/1 76282-571-05, 76282-571-90 ANDA 2019-07-19
Exelan Pharmace oral pregabalin 225 mg/1 76282-574-05, 76282-574-90 ANDA 2019-07-19
Laboratorio Rei intravenous piperacillin and tazobactam 3 g/15mL, .375 g/15mL 76233-277-20 ANDA 2019-07-25
Upsher-Smith La oral morphine sulfate 30 mg/1 0832-0274-11 ANDA 2019-07-22
Upsher-Smith La oral morphine sulfate 15 mg/1 0832-0273-11 ANDA 2019-07-22
Major Pharmaceu oral pregabalin 150 mg/1 0904-7002-61 ANDA 2019-07-19
Major Pharmaceu oral pregabalin 225 mg/1 0904-7004-04 ANDA 2019-07-19
Major Pharmaceu oral pregabalin 300 mg/1 0904-7005-04 ANDA 2019-07-19
ICU Medical Inc irrigation sodium chloride 900 mg/100mL 0990-7972-07 NDA 1982-01-01
ICU Medical Inc irrigation water 1 mL/mL 0990-7973-08 NDA 1982-01-01
Major Pharmaceu oral pregabalin 25 mg/1 0904-6991-04 ANDA 2019-07-19
Major Pharmaceu oral pregabalin 50 mg/1 0904-6992-61 ANDA 2019-07-19
Major Pharmaceu oral pregabalin 100 mg/1 0904-7001-61 ANDA 2019-07-19
ICU Medical Inc irrigation sodium chloride 900 mg/100mL 0990-6138-03, 0990-6138-22 NDA 1982-01-01
ICU Medical Inc irrigation water 1 mL/mL 0990-6139-03, 0990-6139-22 NDA 1982-01-01
ICU Medical Inc irrigation sodium chloride 900 mg/100mL 0990-7138-09, 0990-7138-36 NDA 1982-01-01
ICU Medical Inc irrigation water 1 mL/mL 0990-7139-09, 0990-7139-36 NDA 1982-01-01
Major Pharmaceu oral pregabalin 75 mg/1 0904-7000-61 ANDA 2019-07-19
Major Pharmaceu oral pregabalin 200 mg/1 0904-7003-04 ANDA 2019-07-19
Teva Pharmaceut oral bisoprolol fumarate and hydrochlorothiazide 2.5 mg/1, 6.25 mg/1 0093-3241-01 NDA AUTHORIZED GENERIC 2019-08-07
Teva Pharmaceut oral bisoprolol fumarate and hydrochlorothiazide 10 mg/1, 6.25 mg/1 0093-3243-56 NDA AUTHORIZED GENERIC 2019-08-07
Teva Pharmaceut oral bisoprolol fumarate and hydrochlorothiazide 5 mg/1, 6.25 mg/1 0093-3242-01 NDA AUTHORIZED GENERIC 2019-08-07
Teva Pharmaceut oral pregabalin 50 mg/1 0093-7623-98 ANDA 2019-07-22
Torrent Pharmac topical nystatin 100000 U/g 13668-595-02, 13668-595-01 ANDA 2019-07-24
Teva Pharmaceut oral pregabalin 300 mg/1 0093-7621-98 ANDA 2019-07-22
Teva Pharmaceut oral pregabalin 25 mg/1 0093-7622-98 ANDA 2019-07-22
Teva Pharmaceut oral pregabalin 200 mg/1 0093-7627-98 ANDA 2019-07-22
Teva Pharmaceut oral pregabalin 225 mg/1 0093-7628-98 ANDA 2019-07-22
Teva Pharmaceut oral pregabalin 100 mg/1 0093-7625-98 ANDA 2019-07-22
Teva Pharmaceut oral pregabalin 150 mg/1 0093-7626-98 ANDA 2019-07-22
Teva Pharmaceut oral pregabalin 75 mg/1 0093-7624-98 ANDA 2019-07-22
SteriMax Inc. intramuscular, intravenous cefotaxime injection 2 g/1 21586-012-02 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE 2019-08-01
SteriMax Inc. intramuscular, intravenous cefotaxime injection 1 g/1 21586-011-02 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE 2019-08-01
Sagent Pharmace intramuscular fulvestrant 50 mg/mL 25021-462-74 ANDA 2019-08-01
Hikma Pharmaceu intravenous vecuronium bromide 20 mg/1 0143-9232-10 ANDA 2019-08-01
Hikma Pharmaceu intravenous vecuronium bromide 10 mg/1 0143-9234-10 ANDA 2019-08-01
Laurus Labs Lim oral emtricitabine and tenofovir disoproxil fumarate 200 mg/1, 300 mg/1 42385-913-30, 42385-913-90 ANDA 2019-07-26
Dr.Reddys Labor oral pregabalin 225 mg/1 43598-297-78, 43598-297-66, 43598-297-90, 43598-297-05 ANDA 2019-07-19
Dr.Reddys Labor oral pregabalin 25 mg/1 43598-291-90, 43598-291-66, 43598-291-78, 43598-291-05 ANDA 2019-07-19
Dr.Reddys Labor oral pregabalin 100 mg/1 43598-294-90, 43598-294-66, 43598-294-78, 43598-294-05 ANDA 2019-07-19
Dr.Reddys Labor oral pregabalin 150 mg/1 43598-295-05, 43598-295-90, 43598-295-66, 43598-295-78 ANDA 2019-07-19
Dr.Reddys Labor oral pregabalin 50 mg/1 43598-292-78, 43598-292-05, 43598-292-66, 43598-292-90 ANDA 2019-07-19
Dr.Reddys Labor oral pregabalin 200 mg/1 43598-296-05, 43598-296-66, 43598-296-78, 43598-296-90 ANDA 2019-07-19
Eli Lilly and C nasal glucagon 3 mg/1 0002-6145-11, 0002-6145-27 NDA 2019-07-24
Dr.Reddys Labor oral pregabalin 75 mg/1 43598-293-78, 43598-293-66, 43598-293-90, 43598-293-05 ANDA 2019-07-19
Dr.Reddys Labor oral pregabalin 300 mg/1 43598-298-05, 43598-298-78, 43598-298-66, 43598-298-90 ANDA 2019-07-19
Alembic Pharmac oral pregabalin 225 mg/1 46708-125-91, 46708-125-90, 46708-125-10, 46708-125-30 ANDA 2019-07-19
Alembic Pharmac oral pregabalin 75 mg/1 46708-121-10, 46708-121-30, 46708-121-90, 46708-121-91 ANDA 2019-07-19
Alembic Pharmac oral pregabalin 100 mg/1 46708-122-30, 46708-122-10, 46708-122-91, 46708-122-90 ANDA 2019-07-19
Alembic Pharmac oral pregabalin 200 mg/1 46708-124-91, 46708-124-10, 46708-124-30, 46708-124-90 ANDA 2019-07-19
Alembic Pharmac oral pregabalin 50 mg/1 46708-120-10, 46708-120-30, 46708-120-90, 46708-120-91 ANDA 2019-07-19
Alembic Pharmac oral pregabalin 300 mg/1 46708-126-10, 46708-126-30, 46708-126-71, 46708-126-90 ANDA 2019-07-19
Alembic Pharmac oral pregabalin 25 mg/1 46708-119-10, 46708-119-90, 46708-119-91, 46708-119-30 ANDA 2019-07-19
Alembic Pharmac oral pregabalin 150 mg/1 46708-123-10, 46708-123-30, 46708-123-91, 46708-123-90 ANDA 2019-07-19
SUN PHARMACEUTI oral duloxetine 30 mg/1 47335-617-60, 47335-617-90, 47335-617-10, 47335-617-30 NDA 2019-08-01
SUN PHARMACEUTI oral duloxetine 40 mg/1 47335-618-60, 47335-618-90, 47335-618-10, 47335-618-30 NDA 2019-08-01
SUN PHARMACEUTI oral duloxetine 60 mg/1 47335-619-10, 47335-619-30, 47335-619-90, 47335-619-60 NDA 2019-08-01
SUN PHARMACEUTI oral duloxetine 20 mg/1 47335-616-60, 47335-616-90, 47335-616-30, 47335-616-10 NDA 2019-08-01
RX PHARMA-PACK, sodium chloride 49836-031-04 NDA 1982-01-01
ScieGen Pharmac oral pregabalin 150 mg/1 50228-354-10, 50228-354-30, 50228-354-90 ANDA 2019-07-19
ScieGen Pharmac oral pregabalin 25 mg/1 50228-350-10, 50228-350-90, 50228-350-30 ANDA 2019-07-19
ScieGen Pharmac oral pregabalin 75 mg/1 50228-352-30, 50228-352-90, 50228-352-10 ANDA 2019-07-19
ScieGen Pharmac oral pregabalin 100 mg/1 50228-353-90, 50228-353-10, 50228-353-30 ANDA 2019-07-19
ScieGen Pharmac oral pregabalin 225 mg/1 50228-356-05, 50228-356-90, 50228-356-30 ANDA 2019-07-19
ScieGen Pharmac oral pregabalin 200 mg/1 50228-355-90, 50228-355-30, 50228-355-05 ANDA 2019-07-19
ScieGen Pharmac oral pregabalin 50 mg/1 50228-351-30, 50228-351-10, 50228-351-90 ANDA 2019-07-19
ScieGen Pharmac oral pregabalin 300 mg/1 50228-357-90, 50228-357-30, 50228-357-05 ANDA 2019-07-19
Ingenus Pharmac intravenous vinorelbine 50 mg/5mL 50742-427-05 ANDA 2019-08-08
Ingenus Pharmac intravenous vinorelbine 10 mg/mL 50742-420-01 ANDA 2019-08-08
Bayer HealthCar oral darolutamide 300 mg/1 50419-395-01 NDA 2019-07-31
Golden State Me oral pregabalin 225 mg/1 51407-516-90 ANDA 2019-07-19
Golden State Me oral pregabalin 100 mg/1 51407-512-90 ANDA 2019-07-19
Exela Pharma Sc intravenous sodium bicarbonate 84 mg/mL 51754-5001-5 ANDA 2019-08-01
Golden State Me oral pregabalin 75 mg/1 51407-511-90 ANDA 2019-07-19
Golden State Me oral pregabalin 200 mg/1 51407-514-90 ANDA 2019-07-19
Golden State Me oral pregabalin 25 mg/1 51407-509-90 ANDA 2019-07-19
Golden State Me oral pregabalin 50 mg/1 51407-510-90 ANDA 2019-07-19
Golden State Me oral pregabalin 150 mg/1 51407-513-90 ANDA 2019-07-19
Golden State Me oral pregabalin 300 mg/1 51407-515-90 ANDA 2019-07-19
HF Acquisition intra-articular, intralesional, intramuscular, intravenous, soft tissue dexamethasone sodium phosphate 4 mg/mL 51662-1297-1 ANDA 1982-01-01
Wilshire Pharma oral erythromycin 333 mg/1 52536-183-03, 52536-183-10 ANDA 1982-01-01
Wilshire Pharma oral erythromycin 500 mg/1 52536-186-03, 52536-186-10 ANDA 1982-01-01
Wilshire Pharma oral erythromycin 250 mg/1 52536-180-03, 52536-180-10 ANDA 1982-01-01
Shire US Manufa subcutaneous icatibant acetate 30 mg/3mL 54092-135-02, 54092-135-01 NDA AUTHORIZED GENERIC 2019-07-30
Quality Care Pr oral pregabalin 75 mg/1 55700-775-60, 55700-775-30, 55700-775-90 ANDA 2019-07-19
Quality Care Pr oral pregabalin 100 mg/1 55700-773-90, 55700-773-30, 55700-773-60 ANDA 2019-07-19
Quality Care Pr oral pregabalin 50 mg/1 55700-774-90, 55700-774-60, 55700-774-30 ANDA 2019-07-19
Quality Care Pr oral pregabalin 150 mg/1 55700-776-90, 55700-776-60, 55700-776-30 ANDA 2019-07-19
Quality Care Pr oral hydrocodone bitartrate and acetaminophen 10 mg/1, 325 mg/1 55700-781-60, 55700-781-90, 55700-781-01, 55700-781-30 ANDA 2019-07-26
Aurobindo Pharm oral fenofibric acid 135 mg/1 59651-217-90 ANDA 2019-07-25
Aurobindo Pharm oral fenofibric acid 45 mg/1 59651-216-90 ANDA 2019-07-25
American Health oral pregabalin 100 mg/1 60687-506-01 ANDA 2019-07-25
American Health oral pregabalin 25 mg/1 60687-473-01 ANDA 2019-07-25
American Health oral pregabalin 150 mg/1 60687-517-01 ANDA 2019-07-25
American Health oral pregabalin 50 mg/1 60687-484-01 ANDA 2019-07-25
Direct_Rx oral methadone hydrochloride 10 mg/1 61919-670-60 NDA 1982-01-01
American Health oral pregabalin 75 mg/1 60687-495-01 ANDA 2019-07-25
Diect_Rx oral prednisone 20 mg/1 61919-326-23 ANDA 1982-01-01
Direct_Rx oral gabapentin 800 mg/1 61919-350-30 ANDA 2019-08-08
Dircet_Rx oral glimepiride 2 mg/1 61919-448-90 ANDA 2019-08-08
Direct_Rx oral prednisone 20 mg/1 61919-342-05 ANDA 1982-01-01
Direct_Rx oral gabapentin 800 mg/1 61919-350-60 ANDA 2019-08-08
Direct_Rx oral promethazine hydrochloride 25 mg/1 61919-191-60 ANDA 1982-01-01
Direct_Rx oral prednisone 20 mg/1 61919-326-10 ANDA 1982-01-01
Direct_Rx oral phenazopyridine hydrochloride 200 mg/1 61919-098-06 UNAPPROVED DRUG OTHER 2019-07-30
Direct_Rx oral baclofen 10 mg/1 61919-093-72 ANDA 2019-07-29
Direct_Rx oral gemfibrozil 600 mg/1 61919-967-30 ANDA 2019-08-08
Direct_Rx oral methadone hydrochloride 10 mg/1 61919-670-90 NDA 1982-01-01
Direct_Rx oral glimepiride 2 mg/1 61919-448-30 ANDA 2019-08-08
Alembic Pharmac oral pregabalin 75 mg/1 62332-121-10, 62332-121-90, 62332-121-30, 62332-121-91 ANDA 2019-07-19
Alembic Pharmac oral pregabalin 100 mg/1 62332-122-10, 62332-122-91, 62332-122-30, 62332-122-90 ANDA 2019-07-19
Alembic Pharmac oral pregabalin 150 mg/1 62332-123-10, 62332-123-91, 62332-123-30, 62332-123-90 ANDA 2019-07-19
Alembic Pharmac oral pregabalin 225 mg/1 62332-125-10, 62332-125-30, 62332-125-90, 62332-125-91 ANDA 2019-07-19
Alembic Pharmac oral pregabalin 50 mg/1 62332-120-10, 62332-120-90, 62332-120-30, 62332-120-91 ANDA 2019-07-19
Alembic Pharmac oral pregabalin 200 mg/1 62332-124-91, 62332-124-10, 62332-124-90, 62332-124-30 ANDA 2019-07-19
Alembic Pharmac oral pregabalin 300 mg/1 62332-126-10, 62332-126-30, 62332-126-71, 62332-126-90 ANDA 2019-07-19
Alembic Pharmac oral pregabalin 25 mg/1 62332-119-91, 62332-119-10, 62332-119-30, 62332-119-90 ANDA 2019-07-19
Rising Pharmace oral pregabalin 25 mg/1 64980-410-10, 64980-410-09, 64980-410-01 ANDA 2019-07-19
Rising Pharmace oral pregabalin 300 mg/1 64980-417-09, 64980-417-01, 64980-417-10 ANDA 2019-07-19
Rising Pharmace oral pregabalin 100 mg/1 64980-413-10, 64980-413-09, 64980-413-01 ANDA 2019-07-19
Rising Pharmace oral pregabalin 225 mg/1 64980-416-01, 64980-416-09, 64980-416-10 ANDA 2019-07-19
Caplin Steriles intravenous tranexamic acid 100 mg/mL 65145-106-10 ANDA 2019-07-28
Rising Pharmace oral pregabalin 200 mg/1 64980-415-10, 64980-415-01, 64980-415-09 ANDA 2019-07-19
Rising Pharmace oral pregabalin 150 mg/1 64980-414-09, 64980-414-10, 64980-414-01 ANDA 2019-07-19
Rising Pharmace oral pregabalin 75 mg/1 64980-412-10, 64980-412-09, 64980-412-01 ANDA 2019-07-19
Rising Pharmace oral pregabalin 50 mg/1 64980-411-09, 64980-411-01, 64980-411-10 ANDA 2019-07-19

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

Company Submit Date Subject
R L FINE CHEM P 2019-06-26 CHLORDIAZEPOXIDE
OLON SPA 2019-06-27 LENVATINIB MESYLATE
FARMABIOS SPA 2019-06-26 EPOXIDE DESOXYMETASONE (INTERMEDIATE)
AUROBINDO PHARM 2019-06-26 CARIPRAZINE HYDROCHLORIDE PREMIX
BIOPHORE INDIA 2019-06-18 SELEXIPAG
AUROBINDO PHARM 2019-06-15 FLUOXETINE HYDROCHLORIDE USP (PROCESS II)
EMCURE PHARMACE 2019-06-15 PENTAMIDINE ISETHIONATE USP
SAURAV CHEMICAL 2019-06-06 CHLORZOXAZONE USP
LAURUS LABS LTD 2019-06-25 LOPINAVIR USP
AUROBINDO PHARM 2019-06-07 CLOPIDOGREL BISULFATE USP (FORM II)
MSN LABORATORIE 2019-06-28 BUMETANIDE USP
ALP PHARM BEIJI 2019-06-05 CETRORELIX ACETATE
COSMA SPA 2019-06-11 AMISULPRIDE
AUROBINDO PHARM 2019-06-05 MESALAMINE USP
KAWMAN PHARMA 2019-06-21 MUPIROCIN CALCIUM USP
BRIGHTGENE BIO- 2019-06-06 SUGAMMADEX SODIUM (NON-STERILE, API)
R L FINE CHEM P 2019-05-29 ORPHENADRINE CITRATE
GLAND PHARMA LT 2019-05-31 FLUPHENAZINE DECANOATE
CADILA HEALTHCA 2019-05-29 DARUNAVIR
BRIGHTGENE BIO- 2019-06-06 MICAFUNGIN SODIUM INTERMEDIATE MCB
VIVIN DRUGS AND 2019-06-05 LAMIVUDINE USP
SAFC BIOSCIENCE 2019-05-24 CELL CULTURE MEDIUM CR60219
SAFC BIOSCIENCE 2019-05-24 CELL CULTURE MEDIUM CR60229
CHANGZHOU PHARM 2019-05-22 CAPTOPRIL
MAITHRI DRUGS P 2019-06-12 LUMACAFTOR
SAFC BIOSCIENCE 2019-05-24 CELL CULTURE MEDIUM CR40118
HETERO DRUGS LT 2019-06-10 DEXLANSOPRAZOLE
AUROBINDO PHARM 2019-05-23 TRIFLURIDINE USP
SAFC BIOSCIENCE 2019-05-24 CELL CULTURE MEDIUM CR60234
CRYSTAL PHARMA 2019-06-10 CORTEXOLONE 17a PROPIONATE
MAITHRI DRUGS P 2019-05-31 NITROFURANTOIN HYDROUS USP
MEDICHEM MANUFA 2019-06-17 SUGAMMADEX SODIUM
ARENE LIFESCIEN 2019-05-23 AMLODIPINE BESYLATE USP
PROCOS SPA 2019-06-05 LURASIDONE HYDROCHLORIDE
EMCURE PHARMACE 2019-05-21 ADENOSINE USP
FRESENIUS KABI 2019-06-14 SUGAMMADEX SODIUM
FRESENIUS KABI 2019-06-12 ALECTINIB HYDROCHLORIDE
NORDMARK ARZNEI 2019-05-23 THYROID POWDER
RAKS PHARMA PVT 2019-06-13 METYROSINE USP
R L FINE CHEM P 2019-06-07 DIAZEPAM
AMPHASTAR NANJI 2019-05-19 TERIPARATIDE USP
ARENE LIFESCIEN 2019-06-12 EFAVIRENZ USP
LABORATORI DERI 2019-06-03 HEPARIN SODIUM, USP GRADE
BIOPHORE INDIA 2019-05-30 CARIPRAZINE HYDROCHLORIDE
BIOPHORE INDIA 2019-06-17 DANTROLENE SODIUM
HETERO LABS LTD 2019-05-20 EPLERENONE
APOTEX PHARMACH 2019-05-31 SELEXIPAG
LEK PHARMACEUTI 2019-06-05 SUGAMMADEX SODIUM
AKRON BIOTECHNO 2019-06-05 HUMAN SERUM ALBUMIN 25%, NON-HUMAN USE
QILU TIANHE PHA 2019-05-31 PIPERACILLIN USP (NON-STERILE API)
INDUSTRIALE CHI 2019-06-05 OBETICHOLIC ACID
SUN PHARMACEUTI 2019-06-28 VALSARTAN USP
FERA PHARMACEUT 2019-05-28 PYRIMETHAMINE
CHEMCON GMBH 2019-06-07 ARSENIC TRIOXIDE
ADARE PHARMACEU 2019-06-20 APAP MICROCAPS
LAURUS LABS LTD 2019-06-07 SACUBITRIL VALSARTAN 3NA COMPLEX
AVENTACELL BIOM 2019-05-27 HUMAN FIBRINOGEN DEPLETED PLATELET LYSATE
PRIME EUROPEAN 2019-06-06 PIRENZEPINE BASE PURE
FUXIN LONG RUI 2019-05-30 ENTECAVIR MONOHYDRATE
FUXIN LONG RUI 2019-05-30 PITAVASTATIN CALCIUM
OLON SPA 2019-06-18 TERBINAFINE
INDENA SPA 2019-05-24 THIOTEPA
FORMOSA LABORAT 2019-06-06 PATIROMER SORBITEX CALCIUM
VASUDHA PHARMA 2019-05-27 CLOPIDOGREL BISULFATE USP

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

Company Drug Reason NDCs Date Lot Quantity
NingBo Huize Co DOTS SCENTED ANTIBACTERIAL HAND GEL STRAWBRRY (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181023, Exp 10/22/2020 3852
NingBo Huize Co Tootsie Roll POP ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181015, Exp 10/14/2020 5112
NingBo Huize Co TOOTSIE ROLL FRUIT CHEWS LIME SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181114, Exp 11/13/2020 8,856
Wise Pharmacy Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. Lack of Processing Controls 20190807 Lot #: 6153N, Exp8/29/2019 14 vials
NingBo Huize Co DOTS SCENTED ANTIBACTERIAL HAND GEL LIME (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181022, Exp 10/21/2020 3852
NingBo Huize Co Good to Go Hand Sanitizer (Ethyl Alcohol 62%), 1 FL OZ (30 mL), OTC, Made in China for Cashco Distributors Inc. 6430 N. E. Columbia Blvd Portland OR 97218 CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20180601 Exp 5/31/2020, 20180604 Exp 6/3/2020, 20180820 Exp 8/19/2020, 20180821 Exp 8/20/2020, 20180822 Exp 8/21/2020 52,160
NingBo Huize Co Texas Home Health Home Care Hospice Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20180410, Exp 4/9/2020; 20180411, Exp 4/10/2020; 20180830, Exp 8/29/2020; 20180831, Exp 8/30/2020 50,000
NingBo Huize Co TOOTSIE ROLL SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181115, Exp 11/14/2020 8,856
Wise Pharmacy Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. Lack of Processing Controls 20190807 Lot #: 6176N, Exp 8/30/2019; 7162N, Exp 10/20/2019 32 vials
Jubilant Cadist Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, 59746-763-43 Failed dissolution results at the 3-month stability time point. 59746-763-43, 59746-763-42 20190807 Lot number 183222,exp. date 11/2020. 11,412 cartons/34,236 blister cards/28 pills each card
NingBo Huize Co TOOTSIE ROLL FRUIT CHEWS LEMON SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181112, Exp 11/11/2020 8,856
ImprimisRx NJ Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRX NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979 Subpotent Drug 20190807 Lot #:01252019@1, Exp. 07/21/2019; 03182019@7, Exp. 09/7/2019; 05092019@2, Exp. 11/2/2019 405 bottles
Wise Pharmacy Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO 80123. Lack of Processing Controls 20190807 Lot #: 7131N, Exp 7/11/19 1 bottle
NingBo Huize Co ICEE PEACH SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181130, Exp 11/29/2020; 20181203, Exp 12/2/2020 13,068
Wise Pharmacy Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. Lack of Processing Controls 20190807 Lot #: 5333N, Exp 7/12/2019; 7000N, Exp 10/18/2019 44 vials
Geritrex, LLC Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 52807-177-16 cGMP Deviations: Products may have microbial contamination. 20190731 Lot #: 70601, Exp 6/19 3864 bottles
Pharma-Natural AbeeMed cream (Menthol 1.48% and Histamine DHCL 0.05%), 2 OZ jar, Manufactured exclusively for: Cas, P.O. Box 520248, Miami, FL 33152, UPC 8 50993 00402 4. CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations. 20190731 All lots remaining within expiry. 19422 jars
Tris Pharma Inc Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL), 16 fl. oz. (473 mL) bottle, Rx only, Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 27808-086-02. Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives. 27808-086-02, 27808-086-01 20190731 Lot#: 14079, Exp 10/2021 2,550 bottles
NingBo Huize Co SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunscreen, 53mL/1.8fl.oz., OTC, Distributed by: EVANS, Made in China CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20180709, Exp 07/08/2020; 20180710, Exp 07/09/2020 10, 000
American Health Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-11 Failed Dissolution Specifications: Out of specification result for the dissolution test. 62584-693-11, 62584-693-21 20190807 Lot 172569, Exp 7/31/2019 6,579 cartons
NingBo Huize Co DIPPIN' DOTS SCENTED BIRTHDAY CAKE ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181211, Exp 12/10/2020 13,068
NingBo Huize Co TOOTSIE ROLL FRUIT CHEWS VANILLA SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181113, Exp 11/12/2020 8,856
NingBo Huize Co CHARMS BLOW POP CHERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181025, Exp 10/24/2020; 20181026, Exp 10/25/2020 18036
Wise Pharmacy Dexamethasone Sodium Phosphate PF 24 mg/mL Injection, Refrigerate, Single Use Vial, 1 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. Lack of Processing Controls 20190807 Lots #: 5506N, Exp 9/21/2019; 7180N, Exp 12/29/2019 27 vials
ImprimisRx NJ Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRx NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979 Subpotent Drug 20190807 Lot #: 03132019@2, Exp. 09/17/2019; 05102019@2, Exp. 11/02/2019 246 bottles
Pharma-Natural NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL tsp, Raspberry Flavor, 16 fl oz (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-699-16. CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations. 52083-699-16 20190731 All lots remaining within expiry. 2052 bottles
Deva Holding AS Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07), b) 14-count bottle (NDC 67877-538-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. 67877-538-14, 67877-538-07, 67877-540-14, 67877-541-14, 67877-539-14, 67877-541-07, 67877-537-07, 67877-537-14, 67877-540-07, 67877-539-07, 67877-542-07 20190731 Lot #: a) A061688, A061687, A061685, Exp 07/31/2019; A068994, Exp 04/30/2020; A071853, Exp 09/30/20; b) A061794, A061833, A061822, Exp 07/31/2019; A069115, Exp 04/30/2020; A071855, A071854, Exp 09/30/2020 a) 11376 bottles; b) 13620 bottles
Pharma-Natural Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump, Distributed by: Coast to Coast Natural, Inc., Wellington, FL 33414, NDC 63788-120-04. CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations. 20190731 All lots remaining within expiry. 998 bottles
Geritrex, LLC Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (473 ml), Dist. BY: Gericare Pharmaceuticals corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-403-16 cGMP Deviations: Products may have microbial contamination. 57896-403-16 20190731 Lot #: 70612, Exp 6/19 6165 bottles
Pharma-Natural Dermanak original crema blanqueador (Hydroquinone 2%) Skin Fade Cream, 2 OZ. (56.7 g) jar, Manufactured by: Pamby Distributors, Inc., Miami, FL 33126, NDC 63788-108-02. CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations. 20190731 All lots remaining within expiry. 1032 jars
NingBo Huize Co ICEE LEMON LIME SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181128, Exp 11/27/2020; 20181129, Exp 11/28/2020 13,068
NingBo Huize Co ICEE BLUE RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181206, Exp 12/5/2020; 20181207, Exp 12/6/2020 13,068
NingBo Huize Co DIPPIN' DOTS SCENTED COOKIES 'N CREAM ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181212, Exp 12/11/2020 13,068
NingBo Huize Co AIR HEADS PINK LEMONADE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181122, Exp 11/21/2020; 20181123, Exp 11/22/2020 13,068
NingBo Huize Co AIR HEADS STRAWBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181116, Exp 11/15/2020; 20181119, Exp 11/18/2020 13,068
Wise Pharmacy Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. Lack of Processing Controls 20190807 Lot #: 5620N, Exp 7/16/2019; 6221N, Exp 8/31/2019; 6952N, Exp 10/16/2019 97 vials
NingBo Huize Co Accent Care of New York Home Care Nursing Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20170619, Exp 6/18/2019; 20170620, Exp 6/19/2019; 20170621, Exp 6/20/2019 35,500
Wise Pharmacy Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. Lack of Processing Controls 20190807 Lot #: 6054N; 4796N, Exp 7/16/2019; 7049N, Exp 11/24/2019 84 vials
Wise Pharmacy Gentamicin (GU) Irrigation 240 mg/500 mL Solution, 250 mL Container, Shake well and Refrigerate, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. Lack of Processing Controls 20190807 Lot #: 7179N, Exp 7/16/2019 1 container
NingBo Huize Co AMERICA'S ORIGINAL DUBBLE BUBBLE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181106, Exp 11/5/2020; 20181107, Exp 11/6/2020 20160
NingBo Huize Co Tootsie Roll POP GRAPE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed By: JFL Enterprises, Inc. Cleveland, Ohio 44102, Made in China CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181018, Exp 10/17/2020 5112
H J Harkins Com Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g tube, Rx only, Manufactured for H.J. Harkins Company, Inc. dba Pharma Pac by Perrigo Co, Allegan, MI 49010, NDC 52959-0407-01 CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility. 20190807 Lot #: NPD10RP, Exp 08/19; NPD11RP, Exp 09/19; NPD12RP, Exp 11/19; NPD13RP, Exp 02/20; NPD14RP, Exp 02/20; NPD15RP, Exp 05/20; NPD16RP, Exp 06/20; NPD17RP, Exp 01/21; NPD18RP, Exp 02/21 97 boxes
NingBo Huize Co CHARMS BLOW POP WATERMELON SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181029, Exp 10/28/2020; 20181030, Exp 10/29/2020 18036
NingBo Huize Co AIR HEADS BLUE RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181120, Exp 11/19/2020; 20181121, Exp 11/20/2020 13,068
LNK Internation Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-330-02, UPC 6 8113117595 1 Microbial contamination of non-sterile product 49035-330-02, 49035-330-45, 49035-330-96, 8113117595 20190807 Lot #: P300456, P300475,P300482, P300489, Exp 09/30/2020 P300456, P300475 and P300489 (Total - 13,500 liters) and P300482 - 3,600 liter
MAJOR PHARMACEU DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61. cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations. 0904-6363-45, 0904-6363-61 20190807 Lot# M02250 EXP 10/2020. 828 100-count unit dose cartons
Pharma-Natural Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (113 g) jar, Distributed by Diabetic Supply of Suncoast, Inc., P.O. Box 2102, Vega Alta, PR 00692, NDC 63788-115-04. CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations. 63788-115-04 20190731 All lots remaining within expiry. 1070 jars
Pharma-Natural DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle, Distributed by: Pamby Dist., Miami, FL 33414, NDC 63708-121-04. CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations. 20190731 All lots remaining within expiry. 500 bottles
Geritrex, LLC Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL. Oz. (1 PT.) 473 mL, Manufactured by RIJ Pharmaceutical Corp. 40 Commercial Avenue Middletown, NY 10941, Distributed by Kinray Inc. Whitestone, NY 11357, NDC 53807-216-16 cGMP Deviations: Products may have microbial contamination. 53807-216-16, 53807-216-08 20190731 Lot #: 70603, 70604, 70612, Exp 6/19 15435 bottles
Preferred Pharm Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic Ointment, Pkg Size 3 g Tube, Generic for: Maxitrol, For External Use Only, Rx only, Mfg: Paddock Laboratories, LLC, Preferred Pharmaceuticals, Inc., The Physicians Solutions, Anaheim, CA, NDC 68788-9373-03. CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility. 20190731 Lot #: L2117Q, Batch: 12211717, Exp. 09/2019; F2818H, Batch: 06281808, Exp. 11/2019; B1819T, Batch: B1819T001 to B1819T048 (Inclusive), Exp. 05/2020. 171 tubes
Lupin Pharmaceu Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-519-02 Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle. 68180-519-01, 68180-519-02, 68180-518-02, 68180-518-01, 68180-520-01, 68180-520-02 20190731 Lot #:H801815, Exp. March 2021 11,832 bottles
Bionpharma Inc. Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander Road, Princeton, NJ 08540, NDC 69452-116-45. Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed. 69452-116-45 20190731 Lot #: 18246, Exp 09/2020 3,020 bottles
Wise Pharmacy Papaverine/Phentolamine 30 mg/1 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. Lack of Processing Controls 20190807 Lot #: 5978N, Exp 8/20/2019; 7266N, Exp 11/5/2019 8 vials
NingBo Huize Co DIPPIN' DOTS SCENTED COTTON CANDY ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181213, Exp 12/12/2020 13,068
NingBo Huize Co CHARMS BLOW POP SOUR APPLE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181102, Exp 11/1/2020; 20181105, Exp 11/4/2020 18036
NingBo Huize Co ICEE CHERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181204, Exp 12/3/2020; 20181205, Exp 12/4/2020 13,068
NingBo Huize Co festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunscreen Distributed by: festpak - Austin, TX 78732 Made in China CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181008, Exp 10/07/2020; 20181009, Exp 10/08/2020 20, 000
Piramal Critica Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Primal Critical Care, Inc., 3950 Schelden Circle Bethlehem, PA, 18017, NDC 66794-151-01 Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product. 66794-155-01, 66794-155-02, 66794-156-01, 66794-156-02, 66794-151-01, 66794-157-02, 66794-157-01 20190807 Lot #: 2155-111, 2155-111A, Exp 6/20 Lot 2155-111 (1,418 units) and Lot 2155-111A (5,640 units)
NingBo Huize Co DOTS SCENTED ANTIBACTERIAL HAND GEL LEMON (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181024, Exp 10/23/2020 3852
Pharma-Natural GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL tsp, Cherry Flavor, 16 fl oz (474 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-650-16. CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations. 52083-650-16 20190731 All lots remaining within expiry. 3000 bottles
Pharma-Natural SORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin), 150 mg) in each 7.5 mL 1 1/2 tsp), GRAPE FLAVOR, 16 Fl.oz. (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-660-16. CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations. 52083-660-16 20190731 All lots remaining within expiry. 7392 bottles
Baxter Healthca 0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38. Lack of Assurance of Sterility: Bags have potential to leak. 0338-0049-48, 0338-0049-41, 0338-0049-31, 0338-0043-04, 0338-0049-04, 0338-0049-10, 0338-0049-02, 0338-0049-01, 0338-0049-03, 0338-0049-38, 0338-0049-18, 0338-0043-03, 0338-0049-11 20190731 Lot #s: P389684; P389742, Exp. 8/31/2020 139,680 Containers
Geritrex, LLC Gericare Geri-Tussin DM, 16 FL OZ (473 mL), Geri-care Phamaceuticals Corp. 1650 63rd Street Brooklyn, NY, NDC 57896-660-16 cGMP Deviations: Products may have microbial contamination. 57896-660-16 20190731 Lot #: 70602, Exp 6/19 6213 bottles
Pharma-Natural ARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ (73ML) roll on bottle, Manufactured exclusively for: Crossover Telecom, LLC., P.O. Box 520248, Miami, FL 33122, UPC 8 50993 00408 6. CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations. 20190731 All lots remaining within expiry. 4981 roll on bottles
Geritrex, LLC Ritussin DM Double Strength, 4 FL. OZ. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941 cGMP Deviations: Products may have microbial contamination. 20190731 Lot #: 70611, Exp 6/19 7653 bottles
Pharma-Natural ARMY HEALTH Pain Reliever Gel With CURCUMIN (Menthol 3.00%), 0.5 OZ jar, Manufactured exclusively for: Manufactured exclusively for: Crossover Telecom, LLC., P.O. Box 520248, Miami, FL 33122, UPC 8 50993 00461 1. CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations. 20190731 All lots remaining within expiry. 1508 jars
Deva Holding AS Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-542-07. CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. 67877-538-14, 67877-538-07, 67877-540-14, 67877-541-14, 67877-539-14, 67877-541-07, 67877-537-07, 67877-537-14, 67877-540-07, 67877-539-07, 67877-542-07 20190731 Lot #: A062228, A062227, A062226, A062295, A062294, Exp 08/31/2019; A069325, A069323, Exp 05/31/2020; A072015, Exp 10/31/2020; A076611, A076609, A076608, A076607, Exp 04/30/2021 11472 bottles
Ascend Laborato Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufactured by: Alkem Laboratories, Ltd, Mumbai INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ Failed Dissolution Specifications 20190731 a) Lot# 19140443, exp. date 12/2020, Lot# 19140525, 19140535, exp. date 01/2021 and b) Lot# 19140756, exp. date 12/2020, Lot# 19140757, Lot# 19140758, exp. date 01/2021, Lot# 19141696, Lot# 19141793, exp. date 03/2021 a) 5,472 bottles and b) 5,880 bottles
NingBo Huize Co CHARMS BLOW POP BLUE RAZZ BERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181031, Exp 10/28/2020; 20181101, Exp 10/31/2020 18036
Wise Pharmacy Tobramycin Irrigation 80 mg/1000 mL Solution, 1000 mL Container, Refrigerate, Nasal,, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. Lack of Processing Controls 20190807 Lot #: 7270N, Exp 7/22/2019 1 container
Geritrex, LLC Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-204-04 cGMP Deviations: Products may have microbial contamination. 53807-204-16, 53807-204-04, 53807-204-08 20190731 Lot #: 70606, Exp 6/19 8645 bottles
Dercher Enterpr MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8. Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content. 10481-0112-8 20190731 Batch #: 579634, 579635, Exp 5/2020 277 boxes
Pharma-Natural TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl, 10 mg) in each 5 mL tsp, Grape Flavor, 16 Fl.oz. (474 mL) bottle, Kramer Novis, San Juan, PR 00917, NDC 52083-622-16. CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations. 52083-622-16 20190731 All lots remaining within expiry. 8340 bottles
Geritrex, LLC Ritussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-409-04 cGMP Deviations: Products may have microbial contamination. 53807-409-08, 53807-409-16, 53807-409-28, 53807-409-04 20190731 Lot #: 70602, Exp 6/19 5107 bottles
Pharma-Natural Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain Relieving Topical Analgesic Gel, 4 Oz (113.4 g) jar, Distributed by: Biosfera International Distribution, LLC., Miami Lakes, FL 33016, NDC 63788-118-04. CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations. 20190731 All lots remaining within expiry. 1000 jars
Pharma-Natural Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnica), 2.5oz (71 g) roll on bottle, Exclusively Distributed by: Marketite, LLC., Coral Gables, FL 33134, NDC 72393-201-25. CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations. 72393-201-25 20190731 All lots remaining within expiry. 5273 roll on bottles
Wise Pharmacy Alprostadil 100 mcg/mL Injectable, 2.5 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. Lack of Processing Controls 20190807 Lot #: 6981N, Exp 10/17/2019 4 vials
La Fresh Group, LA FRESH travel lite Sunnyside Lotion Wipe silky, non-greasy formula smooth, soft & moisturizing featuring titanium dioxide, 1 wipe individually wrapped packet, 4.75" x 5.75" (12.0 cm x 14.6 cm) Ingredients: Water, Dimethicone, Dimethiconol, Titanium Dioxide, Benzophenone-3, Octinoxate, Ethylhexylglycerine, Phenoxyethanol, Distributed by La Fresh Group, Inc. Chino, CA 91710 www.LaFreshGroup.com Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling of the product and comments about the product found on e-commerce websites. 20190731 All lots beginning with 453091 83,050 packets
Amneal Pharmace Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08) Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets 20190731 a) Lot # BA10619A, b) Lot # BA10619B, exp. date 07/2020 a) 2,256 bottles; b) 240 bottles
Lupin Pharmaceu Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-545-01 Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation. 68180-545-01, 68180-545-03, 68180-545-02 20190731 Lot #: K800245, Exp. Dec 2019; K900036 Exp. Sep 20; K900153, Exp. 09/2020 33,939 tubes
Deva Holding AS Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-07), b) 14-count bottle (NDC 67877-540-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. 67877-538-14, 67877-538-07, 67877-540-14, 67877-541-14, 67877-539-14, 67877-541-07, 67877-537-07, 67877-537-14, 67877-540-07, 67877-539-07, 67877-542-07 20190731 Lot #: a) A063581, A063462, A063460, Exp 09/30/2019; A063582, Exp 10/31/2019; A069129, Exp 05/31/2020; A071801, Exp 09/30/2020; b) A063639, A063624, A063609, Exp 09/30/2019; A063657, Exp 10/31/2019; A069366, Exp 05/31/2020; A071817, A071819, A071818, Exp 09/30/2020 a) 7380 bottles; b) 10332 bottles
NingBo Huize Co DIPPIN' DOTS SCENTED BANANA SPLIT ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181210, Exp 12/09/2020 13,068
NingBo Huize Co AMERICA'S ORIGINAL DUBBLE BUBBLE Pink Lemonade SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181108, Exp 11/7/2020; 20181109, Exp 11/8/2020 20,160
NingBo Huize Co Lemon Hand Sanitizer (Alcohol 62%), 30 mL / 1.0 fl.oz, OTC, Made in China. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20170410, Exp 04/09/2019; 20170515, Exp 05/14/2019; 20170516, Exp 05/15/2019; 20170517, Exp 05/16/2019; 20170518, Exp 05/17/2019; 20170519, Exp 05/18/2019; 20170522, Exp 05/21/2019; 20170523, Exp 05/22/2019: 20170524, Exp 05/23/2019; 20170525, Exp 05/24/2019; 20170526, Exp 05/25/2019; 20180615, Exp 06/14/2020 126,500
Lupin Pharmaceu Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, MD - 21202 Manufactured by: Lupin Limited Pathampur -454775 India. NDC 68180-903-11 (wallet of 28 tablets) NDC 68180-903-13 (carton of 3 wallets) Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study. 68180-903-11, 68180-903-13 20190807 Lot L800050 12938 units
NingBo Huize Co Tootsie Roll POP RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181017, Exp 10/16/2020 5112
NingBo Huize Co Tootsie Roll POP CHOCOLATE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181016, Exp 10/15/2020 5112
NingBo Huize Co DOTS SCENTED ANTIBACTERIAL HAND GEL ORANGE (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181019, Exp 10/18/2020 3852
NingBo Huize Co AIR HEADS ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. 20190807 Lot #: 20181126, Exp 11/25/2020; 20181127, Exp 11/26/2020 13,068
Geritrex, LLC Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16 cGMP Deviations: Products may have microbial contamination. 20190731 Lot #: 70601, Exp 6/19 3789 bottles
Deva Holding AS Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b) 14-count bottle (NDC 67877-537-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. 67877-538-14, 67877-538-07, 67877-540-14, 67877-541-14, 67877-539-14, 67877-541-07, 67877-537-07, 67877-537-14, 67877-540-07, 67877-539-07, 67877-542-07 20190731 Lot #: a) A062238, A062118, A062115, A062112, A062100, Exp 08/31/2019; A068946, Exp 04/30/2020; A071733, Exp 09/30/2020; b) A062194, A062181, A62275, A062218, Exp 08/31/2019; A069154, Exp 04/30/2020; A071734, A071783, A071735, Exp 09/30/2020 a) 5736 bottles; b) 8460 bottles
Deva Holding AS Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), b) 14-count bottle (NDC 67877-541-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. 67877-538-14, 67877-538-07, 67877-540-14, 67877-541-14, 67877-539-14, 67877-541-07, 67877-537-07, 67877-537-14, 67877-540-07, 67877-539-07, 67877-542-07 20190731 Lot #: a) A061858, A061857, A061856, A061860, A061859, Exp 07/31/2019; A069401, A069402, Exp 05/31/2020; A071978, Exp 09/30/2020; A076736, A076735, Exp 04/30/2021; b) A062031. A062015, A062014, A062050, A062038, Exp 07/31/2019; A069521, A069470, Exp 05/31/2020; A071979, A072014, A072013, Exp 09/30/2020; A076739, A076738, A076737, Exp 04/30/2021 a) 5052 bottles; b) 3816 bottles
Ucb, Inc Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-597-66. Failed Dissolution Specifications. 50474-001-48, 50474-596-40, 50474-595-40, 50474-594-40, 50474-597-66 20190731 Lot: 908946 Exp. 02/2022 2088 bottles
Pharma-Natural Lid O Creme (Lidocaine HCL 4% and Menthol 1%) Topical Analgesic Cream, 2.5 Oz (71 g) roll on bottle, Manufactured & Distributed by: Pharma Natural, Inc. Hialeah, FL 33016, NDC 63788-111-25. CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations. 63788-111-25 20190731 All lots remaining within expiry. 310 roll on bottles
Pharma-Natural Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump, Distributed by: Coast to Coast Natural, Inc., Wellington, FL 33414, NDC 63766-119-04. CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations. 20190731 All lots remaining within expiry. 1000 bottles
Deva Holding AS Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), b) 14-count bottle (NDC 67877-539-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. 67877-538-14, 67877-538-07, 67877-540-14, 67877-541-14, 67877-539-14, 67877-541-07, 67877-537-07, 67877-537-14, 67877-540-07, 67877-539-07, 67877-542-07 20190731 Lot #: a) A061783, A061782, A061781, Exp 07/31/2019; A069128, Exp 05/31/2020; A071923, Exp 09/30/20; b) A061874, A061861, A061896, Exp 07/31/2019; A069326, Exp 05/31/2020; A071924, A071977, A071925, Exp 09/30/2020 a) 13752 bottles; b) 15696 bottles
Pharma-Natural LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.17 Oz (4 g) roll on bottle, Distributed by: Diabetic Supply of Suncoast, Inc., dba Advocate Diabetes, PO Box 2102, Vega Alta, PR 00692, NDC 63788-114-04. CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations. 63788-114-04 20190731 All lots remaining within expiry. 2000 roll on bottles
Pfizer Inc. Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-23, Barcode (01)00304092776233. Lack of Assurance of Sterility: Bags have the potential to leak. 0409-2776-23, 0409-2776-02, 0030409277 20190724 Lot #s: 85-516-KL; 85-517-KL, Exp. 1JAN2020; 86-601-KL; 86-603-KL; 86-618-KL, Exp. 1FEB2020; 87-707-KL, Exp. 1MAR2020; 91-205-KL, Exp. 1JUL2020; 92-306-KL, Exp. 1AUG2020. 280340 bags
Fresenius Kabi Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand] Presence of Particulate Matter; glass particulates 63323-117-61, 63323-117-69, 63323-117-51, 63323-117-59 20190724 Lot 6120420 NDC 63323-117-61, Product Code 101761 and Lot 6120341 NDC 63323-117-69, Product Code NP101761 14,016 vials
Lupin Pharmaceu Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-435-01. Labeling: Missing label; Product complaints reported missing bottle label. 68180-435-01 20190724 Lot #: H805157, Exp. 05/2020 17,238 bottles
Pfizer Inc. Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 mg/200 mL, 200 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-02, Barcode (01)00304092776028. Lack of Assurance of Sterility: Bags have the potential to leak. 0409-2776-23, 0409-2776-02, 0030409277 20190724 Lot #s: 86-615-KL, Exp. 1FEB2020; 87-701-KL, Exp. 1MAR2020; 90-114-KL, Exp. 1JUN2020 58200 bags

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