Wizmed Logo
One Search
Connect with us
Request a demo

Need help understanding all the information below? Feel free to contact us or view our video tutorials.

WIZMED sources is data from the FDA, Dailymed, Medicaid data and other data sources and uses calculations to attempt to align datasets. The data feeds may 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.

FDA Drug NDCs / Labels

162

Labels

NDA Filings Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride , calcium acetate , Fish oil , LIDOCAINE HYDROCHLORIDE , HEPARIN SODIUM , Morphine Sulfate , Argatroban , Daptomycin , LEVOTHYROXINE SODIUM ANHYDROUS , INDOMETHACIN , Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic , ROPIVACAINE HYDROCHLORIDE , TOBRAMYCIN SULFATE , BUPIVACAINE HYDROCHLORIDE , Glucagon , Fulvestrant , Levothyroxine Sodium , Tigecycline , LINEZOLID , Hydromorphone hydrochloride , iron sucrose , sucroferric oxyhydroxide , PROPOFOL , CHLOROPROCAINE HYDROCHLORIDE , LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE , MAGNESIUM SULFATE HEPTAHYDRATE , clevidipine , Neostigmine Methylsulfate , Atropine Sulfate , Bortezomib , FUROSEMIDE , PENTAMIDINE ISETHIONATE , Caspofungin Acetate , MOXIFLOXACIN HYDROCHLORIDE , OXYTOCIN , Calcium Gluconate , BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE , Anticoagulant Sodium Citrate Solution , Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine , Smoflipid , ACETAMINOPHEN , PALONOSETRON HYDROCHLORIDE

Authorized Generic Drugs enoxaparin sodium , Calcium Acetate

ANDAs (Approved New Drug Applications) SODIUM CHLORIDE , IRINOTECAN HYDROCHLORIDE , FLUPHENAZINE HYDROCHLORIDE , VANCOMYCIN HYDROCHLORIDE , MEPIVACAINE HYDROCHLORIDE , TOBRAMYCIN SULFATE , GANCICLOVIR SODIUM , Imipenem and Cilastatin Sodium , Nafcillin Sodium , NAFCILLIN , OCTREOTIDE ACETATE , AZTREONAM , FOSPHENYTOIN SODIUM , CAFFEINE CITRATE , BUPIVACAINE HYDROCHLORIDE , Enoxaparin Sodium , ESMOLOL HYDROCHLORIDE , TERBUTALINE SULFATE , Vecuronium Bromide , Fentanyl Citrate , Zoledronic Acid , POTASSIUM CHLORIDE , Piperacillin and Tazobactam , ampicillin sodium , Metoclopramide Hydrochloride , Heparin Sodium , Lactulose , FLUOROURACIL , MITOXANTRONE HYDROCHLORIDE , IFOSFAMIDE , KETOROLAC TROMETHAMINE , Water , PYRIDOXINE HYDROCHLORIDE , LIDOCAINE HYDROCHLORIDE , PROTAMINE SULFATE , CEFAZOLIN SODIUM , PIPERACILLIN SODIUM,TAZOBACTAM SODIUM , LEVOFLOXACIN , Daptomycin , COLISTIMETHATE SODIUM , AZITHROMYCIN MONOHYDRATE , LEVETIRACETAM , HALOPERIDOL DECANOATE , VALPROATE SODIUM , DEXAMETHASONE SODIUM PHOSPHATE , Bivalirudin , Glycopyrrolate , PROPRANOLOL HYDROCHLORIDE , Remifentanil Hydrochloride , MESNA , Famotidine , Phenylephrine Hydrochloride , GEMCITABINE , MAGNESIUM SULFATE HEPTAHYDRATE , DOXYCYCLINE , Sumatriptan Succinate , VINBLASTINE SULFATE , CLINDAMYCIN PHOSPHATE , Cefoxitin Sodium , Dimenhydrinate , FLUMAZENIL , Meropenem , DEFEROXAMINE MESYLATE , hydrALAZINE Hydrochloride , Dextrose Monohydrate , ADENOSINE , Palonosetron , ACETYLCYSTEINE , Micafungin Sodium , Ertapenem Sodium , Midazolam Hydrochloride , Piperacillin Sodium and Tazobactam Sodium , ACYCLOVIR SODIUM , Ceftriaxone , RIFAMPIN , Dexmedetomidine Hydrochloride , Leucovorin calcium , DIPHENHYDRAMINE HYDROCHLORIDE , Melphalan Hydrochloride , Azacitidine , Methocarbamol , Amikacin Sulfate , Busulfan , THIAMINE HYDROCHLORIDE , FLOXURIDINE , GENTAMICIN , METHYLPREDNISOLONE SODIUM SUCCINATE , FLUPHENAZINE DECANOATE , ROCURONIUM BROMIDE , clofarabine , MILRINONE LACTATE , CHLOROTHIAZIDE SODIUM , TOPOTECAN HYDROCHLORIDE , Paclitaxel , BENZTROPINE MESYLATE , haloperidol lactate , GENTAMICIN SULFATE , CHLORAMPHENICOL SODIUM SUCCINATE , CYANOCOBALAMIN , GRANISETRON HYDROCHLORIDE , Cefepime , CISATRACURIUM BESYLATE , SODIUM ACETATE , DOXORUBICIN HYDROCHLORIDE , CISPLATIN , BLEOMYCIN SULFATE , CARBOPLATIN , Polymyxin B Sulfate , ONDANSETRON HYDROCHLORIDE , BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE , Oxaliplatin , ETOPOSIDE , METHOTREXATE SODIUM , DACARBAZINE , CLADRIBINE , PROGESTERONE , Tranexamic Acid , AMIODARONE HYDROCHLORIDE , FOSAPREPITANT , MANNITOL , SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE , FLUDARABINE PHOSPHATE , BACITRACIN , CEFOTETAN DISODIUM , LINEZOLID , CYTARABINE , Folic Acid , Arsenic Trioxide , METOPROLOL TARTRATE , Decitabine , Dicyclomine Hydrochloride , CLONIDINE HYDROCHLORIDE , DAUNORUBICIN HYDROCHLORIDE , DEXTROSE; SODIUM CHLORIDE , DIPYRIDAMOLE , EPIRUBICIN HYDROCHLORIDE , FLUCONAZOLE , IDARUBICIN HYDROCHLORIDE , OXACILLIN SODIUM , PAMIDRONATE DISODIUM , PIPERACILLIN SODIUM; TAZOBACTAM SODIUM , VINORELBINE TARTRATE , ICATIBANT ACETATE , EPHEDRINE SULFATE , ANASTROZOLE

Unapproved Drugs PROPOFOL , Sodium Chloride , SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE , hydroxyprogesterone caproate , WATER , POTASSIUM PHOSPHATE, MONOBASIC and POTASSIUM PHOSPHATE, DIBASIC , SODIUM GLYCOLATE

BLA Chorionic Gonadotropin

private labels NovaPlus Premier Intalere Northstar Civica BluePoint Schein (HF or GI)
Vertically Integrated (estimated) lactulo, paclita, irinote, oxalipl, ceftria, anastro, gemcita, ampicil, busulfa, decitab, piperac, ropivac, cefepim,

FDA Approved Drug Filings

155

Active
FDA Drugs Approvals Returned: CALCIUM ACETATE , VANCOMYCIN HYDROCHLORIDE , AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN , FISH OIL TRIGLYCERIDES , FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL , PENTAMIDINE ISETHIONATE , ACYCLOVIR SODIUM , ADENOSINE , AMIKACIN SULFATE , AMIODARONE HYDROCHLORIDE , ARGATROBAN , ARSENIC TRIOXIDE , MORPHINE SULFATE , AZITHROMYCIN , AZTREONAM , BACITRACIN , SODIUM CHLORIDE , BENZTROPINE MESYLATE , BLEOMYCIN SULFATE , CALCITRIOL , CARBOPLATIN , CEFAZOLIN SODIUM , CEFOTAXIME SODIUM , CEFOTETAN DISODIUM , CEFOXITIN SODIUM , CEFTRIAXONE SODIUM , CEFUROXIME SODIUM , CHLORAMPHENICOL SODIUM SUCCINATE , CHLOROTHIAZIDE SODIUM , CIPROFLOXACIN , CISATRACURIUM BESYLATE , CISPLATIN , CLADRIBINE , CLINDAMYCIN PHOSPHATE , CLONIDINE HYDROCHLORIDE , COLISTIMETHATE SODIUM , CYANOCOBALAMIN , CYTARABINE , DACARBAZINE , DAUNORUBICIN HYDROCHLORIDE , DEFEROXAMINE MESYLATE , DEXAMETHASONE SODIUM PHOSPHATE , DEXMEDETOMIDINE HYDROCHLORIDE , DEXTROSE , DEXTROSE; SODIUM CHLORIDE , DICYCLOMINE HYDROCHLORIDE , HYDROMORPHONE HYDROCHLORIDE , DIMENHYDRINATE , DIPHENHYDRAMINE HYDROCHLORIDE , PROPOFOL , DIPYRIDAMOLE , DOXORUBICIN HYDROCHLORIDE , DOXYCYCLINE HYCLATE , EPIRUBICIN HYDROCHLORIDE , ESMOLOL HYDROCHLORIDE , ETOPOSIDE , FAMOTIDINE , FENTANYL CITRATE , FLOXURIDINE , FLUCONAZOLE , FLUDARABINE PHOSPHATE , FLUMAZENIL , FLUOROURACIL , FLUPHENAZINE DECANOATE , FLUPHENAZINE HYDROCHLORIDE , FOLIC ACID , FOSPHENYTOIN SODIUM , FUROSEMIDE , GANCICLOVIR SODIUM , GEMCITABINE HYDROCHLORIDE , GENTAMICIN SULFATE , GLYCOPYRROLATE , GRANISETRON HYDROCHLORIDE , HALOPERIDOL LACTATE , HALOPERIDOL DECANOATE , HEPARIN SODIUM , HYDRALAZINE HYDROCHLORIDE , HYDROXYZINE HYDROCHLORIDE , IDARUBICIN HYDROCHLORIDE , IFOSFAMIDE , INDOMETHACIN , SOYBEAN OIL , IOPAMIDOL , IRINOTECAN HYDROCHLORIDE , KANAMYCIN SULFATE , KETOROLAC TROMETHAMINE , CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE , LEUCOVORIN CALCIUM , LEVOFLOXACIN , LIDOCAINE HYDROCHLORIDE , MAGNESIUM SULFATE , MANNITOL , MELPHALAN HYDROCHLORIDE , METARAMINOL BITARTRATE , METHOTREXATE SODIUM , METHYLPREDNISOLONE SODIUM SUCCINATE , METOCLOPRAMIDE HYDROCHLORIDE , METOPROLOL TARTRATE , MIDAZOLAM HYDROCHLORIDE , MILRINONE LACTATE , MITOXANTRONE HYDROCHLORIDE , NAFCILLIN SODIUM , CHLOROPROCAINE HYDROCHLORIDE , OCTREOTIDE ACETATE , ONDANSETRON HYDROCHLORIDE , OXACILLIN SODIUM , OXYTOCIN , PACLITAXEL , PAMIDRONATE DISODIUM , PHENYTOIN SODIUM , PIPERACILLIN SODIUM; TAZOBACTAM SODIUM , MEPIVACAINE HYDROCHLORIDE , POLYMYXIN B SULFATE , POTASSIUM CHLORIDE , PROGESTERONE , PROPRANOLOL HYDROCHLORIDE , PROTAMINE SULFATE , PYRIDOXINE HYDROCHLORIDE , REMIFENTANIL HYDROCHLORIDE , RIFAMPIN , ROCURONIUM BROMIDE , BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE , BUPIVACAINE HYDROCHLORIDE , SODIUM ACETATE , TERBUTALINE SULFATE , THIAMINE HYDROCHLORIDE , THIOTEPA , TOBRAMYCIN SULFATE , TOPOTECAN HYDROCHLORIDE , TRANEXAMIC ACID , VALPROATE SODIUM , VINBLASTINE SULFATE , VINCRISTINE SULFATE , VINORELBINE TARTRATE , EPINEPHRINE; LIDOCAINE HYDROCHLORIDE , ACETYLCYSTEINE , BIVALIRUDIN , LEVETIRACETAM , MESNA , MICAFUNGIN SODIUM , OXALIPLATIN , PALONOSETRON HYDROCHLORIDE , ZOLEDRONIC ACID , ICATIBANT ACETATE , SUMATRIPTAN SUCCINATE , STERILE WATER FOR INJECTION , GLUCAGON HYDROCHLORIDE , BORTEZOMIB , CASPOFUNGIN ACETATE , DAPTOMYCIN , FOSAPREPITANT DIMEGLUMINE , LEVOTHYROXINE SODIUM , TIGECYCLINE , METHOCARBAMOL , ROPIVACAINE HYDROCHLORIDE , FULVESTRANT , CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE , CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE , ACETAMINOPHEN , CAFFEINE CITRATE , CALCIUM GLUCONATE , EPHEDRINE SULFATE , LINEZOLID , MOXIFLOXACIN HYDROCHLORIDE , NEOSTIGMINE METHYLSULFATE , PHENYLEPHRINE HYDROCHLORIDE , POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC , ATROPINE SULFATE , LACTULOSE , SUCROFERRIC OXYHYDROXIDE , ANASTROZOLE , BICALUTAMIDE , LETROZOLE

Active Approvals / Active Suppliers: FRESENIUS MEDCL , FRESENIUS KABI USA , FRESENIUS , FRESENIUS KABI , VIFOR FRESENIUS

Active Pharmaceutical Ingredients

37>

Active
Companies with Active, Active Pharmaceutical Ingredients FRESENIUS KABI AUSTRIA GMBH , FRESENIUS KABI IPSUM SRL , FRESENIUS KABI ONCOLOGY LTD

Active Pharmaceutical Ingredients Returned from the Search LACTULOSE CONCENTRATE USP , LACTULOSE CRYSTALS , LACTULOSE SOLUTION USP , AMPICILLIN SODIUM STERILE , AMPICILLIN SODIUM/SULBACTAM SODIUM , AMPICILLIN TRIHYDRATE STERILE , BUFFERED CEFTAZIDIME PENTAHYDRATE, STERILE , BUFFERED NAFCILLIN SODIUM STERILE , BUFFERED OXACILLIN SODIUM STERILE , BUFFERED PENICILLIN G POTASSIUM STERILE , BUFFERED PENICILLIN G SODIUM STERILE , CEFEPIME ARGININE STERILE , CEFEPIME HYDROCHLORIDE STERILE , CEFTRIAXONE SODIUM STERILE , CLOXACILLIN BENZATHINE STERILE , HETACILLIN POTASSIUM STERILE , PENICILLIN G SODIUM STERILE , PIPERACILLIN SODIUM/ TAZOBACTAM SODIUM (8:1) STERILE LYOPHILIZED , AFATINIB DIMALEATE , ALECTINIB HYDROCHLORIDE , ANASTROZOLE , BELINOSTAT , BENDAMUSTINE HYDROCHLORIDE , BICALUTAMIDE , BUSULFAN , CARFILZOMIB , DECITABINE , DOCETAXEL , GEMCITABINE HYDROCHLORIDE , IBRUTINIB , IRINOTECAN HYDROCHLORIDE TRIHYDRATE , LETROZOLE , OXALIPLATIN , PACLITAXEL SEMISYNTHETIC , PLERIXAFOR , ROPIVACAINE HYDROCHLORIDE , SUGAMMADEX SODIUM

Tentative FDA Drug Approvals

5

Tentative Approvals
FRESENIUS KABI USA - GEMCITABINE HYDROCHLORIDE - EQ 200MG BASE/VIAL - INJECTABLE; INJECTION
FRESENIUS KABI USA - GEMCITABINE HYDROCHLORIDE - EQ 1GM BASE/VIAL - INJECTABLE; INJECTION
FRESENIUS KABI USA - CABAZITAXEL - 20MG/ML - INJECTABLE;INJECTION
FRESENIUS KABI USA - DEXMEDETOMIDINE HYDROCHLORIDE - EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) - INJECTABLE;INJECTION
FRESENIUS KABI USA - BENDAMUSTINE HYDROCHLORIDE - 100MG/4ML (25MG/ML) - SOLUTION;IV (INFUSION)

Shared Drug Filings

77

Filings

FDA Drug Shortages

50

Total
Currently in Shortage 34
Drug Shortage Resolved 13
Drug to be Discontinued 1

Pharma Drug Patents

35

Patents
FRESENIUS MEDCL patent for PHOSLYRA ( CALCIUM ACETATE) for U-1469: USE OF PHOSLYRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS with EXPIRY of 2027-07-20

FRESENIUS MEDCL patent for PHOSLYRA ( CALCIUM ACETATE) for U-1469: USE OF PHOSLYRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS with EXPIRY of 2027-07-20

FRESENIUS KABI USA patent for MORPHINE SULFATE ( MORPHINE SULFATE) for U-43: MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA with EXPIRY of 2034-03-12

FRESENIUS KABI USA patent for MORPHINE SULFATE ( MORPHINE SULFATE) for U-55: TREATMENT OF PAIN with EXPIRY of 2034-03-12

VIFOR FRESENIUS patent for VELPHORO ( SUCROFERRIC OXYHYDROXIDE) for U-1468: CONTROL OF PHOSPHOROUS LEVELS IN PATIENTS with EXPIRY of 2030-01-23

VIFOR FRESENIUS patent for VELPHORO ( SUCROFERRIC OXYHYDROXIDE) for U-1468: CONTROL OF PHOSPHOROUS LEVELS IN PATIENTS with EXPIRY of 2020-06-12

FRESENIUS KABI USA patent for FULVESTRANT ( FULVESTRANT) for U-2540: TREATMENT OF HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN with EXPIRY of 2034-05-17

FRESENIUS KABI USA patent for OMEGAVEN ( FISH OIL TRIGLYCERIDES) for U-2585: TREATMENT OF PARENTERAL NUTRITION-ASSOCIATED CHOLESTASIS IN PATIENTS UNDER THE AGE OF 12 with EXPIRY of 2024-11-05

FRESENIUS KABI USA patent for OMEGAVEN ( FISH OIL TRIGLYCERIDES) for U-2367: USE FOR PATIENTS WITH PARENTERAL NUTRITION ASSOCIATED CHOLESTASIS OR PARENTERAL NUTRITION ASSOCIATED LIVER DISEASE with EXPIRY of 2025-07-11

FRESENIUS MEDCL patent for PHOSLYRA ( CALCIUM ACETATE) for U-1469: USE OF PHOSLYRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS with EXPIRY of 2030-02-23

FRESENIUS KABI USA patent for FULVESTRANT ( FULVESTRANT) for U-2540: TREATMENT OF HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN with EXPIRY of 2034-02-14

FRESENIUS KABI USA patent for OMEGAVEN ( FISH OIL TRIGLYCERIDES) for U-2366: TREATMENT OF LIVER DISEASE THROUGH NUTRITION FOR PATIENTS UNDER THE AGE OF 12 with EXPIRY of 2025-07-11

FRESENIUS KABI USA patent for FULVESTRANT ( FULVESTRANT) for U-2540: TREATMENT OF HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN with EXPIRY of 2034-02-14

FRESENIUS KABI USA patent for DILAUDID ( HYDROMORPHONE HYDROCHLORIDE) for : with EXPIRY of 2032-04-23

VIFOR FRESENIUS patent for VELPHORO ( SUCROFERRIC OXYHYDROXIDE) for : with EXPIRY of 2028-11-13

FRESENIUS KABI USA patent for DILAUDID ( HYDROMORPHONE HYDROCHLORIDE) for : with EXPIRY of 2020-11-09

FRESENIUS KABI USA patent for DIPRIVAN ( PROPOFOL) for : with EXPIRY of 2024-12-01

FRESENIUS KABI USA patent for DILAUDID ( HYDROMORPHONE HYDROCHLORIDE) for : with EXPIRY of 2034-03-12

FRESENIUS KABI USA patent for LEVOTHYROXINE SODIUM ( LEVOTHYROXINE SODIUM) for : with EXPIRY of 2032-08-29

FRESENIUS KABI USA patent for NAROPIN ( ROPIVACAINE HYDROCHLORIDE) for : with EXPIRY of 2024-05-23

FRESENIUS KABI USA patent for NAROPIN ( ROPIVACAINE HYDROCHLORIDE) for : with EXPIRY of 2025-10-18

FRESENIUS MEDCL patent for PHOSLO GELCAPS ( CALCIUM ACETATE) for : with EXPIRY of 2021-04-03

FRESENIUS KABI USA patent for LEVOTHYROXINE SODIUM ( LEVOTHYROXINE SODIUM) for : with EXPIRY of 2032-08-29

FRESENIUS KABI USA patent for ACETAMINOPHEN ( ACETAMINOPHEN) for : with EXPIRY of 2030-04-19

FRESENIUS KABI USA patent for LEVOTHYROXINE SODIUM ( LEVOTHYROXINE SODIUM) for : with EXPIRY of 2036-12-01

FRESENIUS KABI USA patent for DILAUDID-HP ( HYDROMORPHONE HYDROCHLORIDE) for : with EXPIRY of 2020-11-09

FRESENIUS MEDCL patent for PHOSLO GELCAPS ( CALCIUM ACETATE) for : with EXPIRY of 2021-07-30

FRESENIUS KABI USA patent for LEVOTHYROXINE SODIUM ( LEVOTHYROXINE SODIUM) for : with EXPIRY of 2036-12-01

FRESENIUS KABI USA patent for NAROPIN ( ROPIVACAINE HYDROCHLORIDE) for : with EXPIRY of 2026-11-28

FRESENIUS KABI USA patent for MORPHINE SULFATE ( MORPHINE SULFATE) for : with EXPIRY of 2034-03-12

FRESENIUS KABI USA patent for DILAUDID-HP ( HYDROMORPHONE HYDROCHLORIDE) for : with EXPIRY of 2032-04-23

FRESENIUS KABI USA patent for NAROPIN ( ROPIVACAINE HYDROCHLORIDE) for : with EXPIRY of 2023-05-18

VIFOR FRESENIUS patent for VELPHORO ( SUCROFERRIC OXYHYDROXIDE) for : with EXPIRY of 2028-11-13

FRESENIUS KABI USA patent for MORPHINE SULFATE ( MORPHINE SULFATE) for : with EXPIRY of 2034-03-12

FRESENIUS KABI USA patent for LEVOTHYROXINE SODIUM ( LEVOTHYROXINE SODIUM) for : with EXPIRY of 2032-10-03

FRESENIUS MEDCL patent for PHOSLO ( CALCIUM ACETATE) for : with EXPIRY of 2021-04-03

FRESENIUS KABI USA patent for DILAUDID-HP ( HYDROMORPHONE HYDROCHLORIDE) for : with EXPIRY of 2034-03-12

FRESENIUS KABI USA patent for CASPOFUNGIN ACETATE ( CASPOFUNGIN ACETATE) for : with EXPIRY of 2032-12-21

VIFOR FRESENIUS patent for VELPHORO ( SUCROFERRIC OXYHYDROXIDE) for : with EXPIRY of 2034-11-26

FRESENIUS KABI USA patent for BORTEZOMIB ( BORTEZOMIB) for : with EXPIRY of 2032-11-03

FRESENIUS KABI USA patent for DIPRIVAN ( PROPOFOL) for : with EXPIRY of 2025-06-01


FDA Drug Exclusivity

10

Exclusivities
FRESENIUS KABI USA FISH OIL TRIGLYCERIDES - OMEGAVEN - 10GM/100ML (0.1GM/ML) - NCE:NEW CHEMICAL ENTITY -2023-07-27
FRESENIUS KABI USA FISH OIL TRIGLYCERIDES - OMEGAVEN - 10GM/100ML (0.1GM/ML) - ODE-202:ORPHAN DRUG EXCLUSIVITY -2025-07-27
FRESENIUS KABI USA FISH OIL TRIGLYCERIDES - OMEGAVEN - 5GM/50ML (0.1GM/ML) - NCE:NEW CHEMICAL ENTITY -2023-07-27
FRESENIUS KABI USA FISH OIL TRIGLYCERIDES - OMEGAVEN - 5GM/50ML (0.1GM/ML) - ODE-202:ORPHAN DRUG EXCLUSIVITY -2025-07-27
FRESENIUS KABI USA FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL - SMOFLIPID 20% - 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) - NCE:NEW CHEMICAL ENTITY -2021-07-13
FRESENIUS KABI USA FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL - SMOFLIPID 20% - 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) - NCE:NEW CHEMICAL ENTITY -2021-07-13
FRESENIUS KABI USA FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL - SMOFLIPID 20% - 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) - NCE:NEW CHEMICAL ENTITY -2021-07-13
FRESENIUS KABI USA FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL - SMOFLIPID 20% - 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) - NCE:NEW CHEMICAL ENTITY -2021-07-13
FRESENIUS KABI USA MICAFUNGIN SODIUM - MICAFUNGIN SODIUM - EQ 100MG BASE/VIAL - PC:PATENT CHALLENGE -2020-11-07
FRESENIUS KABI USA MICAFUNGIN SODIUM - MICAFUNGIN SODIUM - EQ 50MG BASE/VIAL - PC:PATENT CHALLENGE -2020-11-07

Federal Supply Schedule Pricing

2

Vendors on FSS
Companies on Federal Supply Schedule Fresenius Kabi, LLC , Fresenius USA, Inc.

Pharmaceutical Drugs on Federal Supply Schedule ACYCLOVIR NA 50MG/ML INJ , ADENOSINE 3MG/ML INJ , ADENOSINE 3MG/ML INJ,SYRINGE 2ML , ADENOSINE 3MG/ML INJ,SYRINGE 4ML , ADENOSINE 3MG/ML INJ,VIL,20ML , ADENOSINE 3MG/ML INJ,VIL,30ML , AMIKACIN SO4 250MG/ML INJ , AMIODARONE HCL 50MG/ML INJ,9ML , AMIODARONE HCL 50MG/ML INJ,AMP,3ML , AMPICILLIN NA 1GM/VIL INJ , AMPICILLIN NA 250MG/VIL INJ , AMPICILLIN NA 2GM/VIL INJ , AMPICILLIN NA 500MG/VIL INJ , ARGATROBAN 100MG/ML INJ,CONC , ARSENIC TRIOXIDE 1MG/ML INJ , ATROPINE SO4 0.4MG/ML INJ , AZITHROMYCIN DIHYDRATE 500MG/VIL INJ , AZTREONAM 1GM/VIL INJ , AZTREONAM 2GM/VIL INJ , BENZTROPINE MESYLATE 1MG/ML INJ , BIVALIRUDIN 250MG/VIL INJ , BORTEZOMIB 3.5MG/VIL INJ , BUPIVACAINE HCL 0.25% INJ , BUPIVACAINE HCL 0.25%/EPINEPHRINE 1:200000 INJ , BUPIVACAINE HCL 0.5% INJ , BUPIVACAINE HCL 0.5%/EPINEPHRINE 1:200000 INJ , BUPIVACAINE HCL 125MG/50ML VIL INJ , BUPIVACAINE HCL 150MG/30ML VIL INJ , BUPIVACAINE HCL 225MG/30ML VIL INJ , BUPIVACAINE HCL 225MG/EPINEPHRINE VIL INJ , BUPIVACAINE HCL 250MG/50ML VIL INJ , BUPIVACAINE HCL 25MG/10ML VIL INJ , BUPIVACAINE HCL 25MG/50ML VIL INJ , BUPIVACAINE HCL 50MG/10ML W/EPINEPHRINE VIL INJ , BUPIVACAINE HCL 75MG/10ML SOLN , BUPIVACAINE HCL 75MG/30ML VIL INJ , BUPIVICAINE HCL 125MG/50ML/EPINEPHRINE VIL INJ , CAFFEINE CITRATE 20MG/ML INJ , CALCIUM GLUCONATE 100MG/ML INJ , CASPOFUNGIN ACETATE 50 MG, VIAL , CASPOFUNGIN ACETATE 70 MG, VIAL , CEFAZOLIN NA 10GM/VIL INJ , CEFAZOLIN NA 1GM/VIL INJ , CEFAZOLIN NA 500MG/VIL INJ , CEFOTETAN DISODIUM 1GM/VIL INJ , CEFOTETAN DISODIUM 2GM/VIL INJ , CEFOXITAN NA 1GM/VIL INJ , CEFOXITIN NA 2GM/VIL INJ , CEFTRIAXONE NA 1GM/VIL INJ , CHLORAMPHENICOL NA SUCCINATE 1GM/VIL INJ , CHLOROPROCAINE HCL 1% INJ , CHLOROPROCAINE HCL 2% INJ , CHLOROPROCAINE HCL 3% INJ , CHLOROTHIAZIDE NA 500MG/VIL INJ , CILASTATIN NA 250MG/IMIPENEM 250MG/VIL INJ IV , CILASTATIN NA 500MG/IMIPENEM 500MG/VIL INJ IV , CISATRACURIUM BESYLATE 10MG/ML INJ,SOLN , CISATRACURIUM BESYLATE 2MG/ML INJ,SOLN , CISPLATIN 100MG/VIL (PF) INJ , CISPLATIN 200MG/VIL (PF) INJ , CISPLATIN 50MG/VIL INJ , CLADRIBINE 1MG/ML INJ , COLISTIMETHATE NA 150MG/VIL INJ , CYANOCOBALAMIN 1000MCG/ML INJ , CYTARABINE 2GM/VIL INJ , DACARBAZINE 100MG/VIL INJ , DACARBAZINE 200MG/VIL INJ , DAPTOMYCIN 350MG/VIL INJ , DAPTOMYCIN 500MG/VIL INJ , DEFEROXAMINE MESYLATE 2GM/VIL INJ , DEFEROXAMINE MESYLATE 500MG/VIL INJ , DEXAMETHASONE NA PHOSPHATE 10MG/ML INJ,SOLN , DEXAMETHASONE NA PHOSPHATE 10MG/ML INJ,SOLN,SYRINGE,1ML , DEXAMETHASONE NA PHOSPHATE 4MG/ML INJ,SOLN , DEXAMETHASONE NA PHOSPHATE 4MG/ML INJ,SOLN,SYRINGE,1ML , DEXMEDETOMIDINE 4MCG/ML/0.9% NACL INJ,BAG,100ML , DEXMEDETOMIDINE 4MCG/ML/0.9% NACL INJ,BAG,20ML , DEXMEDETOMIDINE 4MCG/ML/0.9% NACL INJ,BAG,50ML , DEXMEDETOMIDINE HCL 100MCG/ML INJ , DEXTROSE 10% INJ,BAG,1000ML , DEXTROSE 10% INJ,BAG,250ML , DEXTROSE 10% INJ,BAG,500ML , DEXTROSE 5% INJ,BAG,1000ML , DEXTROSE 5% INJ,BAG,100ML , DEXTROSE 5% INJ,BAG,250ML , DEXTROSE 5% INJ,BAG,500ML , DEXTROSE 5% INJ,BAG,50ML , DIMENHYDRINATE 50MG/ML INJ , DIPHENHYDRAMINE HCL 50MG/ML INJ , DOXORUBICIN HCL 2MG/ML INJ , DOXYCYCLINE HYCLATE 100MG/VIL INJ , ENOXAPARIN 100MG/ML INJ , ENOXAPARIN 120MG/0.8ML INJ,SYRINGE,0.8ML , ENOXAPARIN 150MG/ML INJ,SYRINGE,1ML , ENOXAPARIN 30MG/ML INJ , ENOXAPARIN 40MG/ML INJ , ENOXAPARIN 60MG/ML INJ , ENOXAPARIN 80MG/ML INJ , ERTAPENEM 1GM/VIL INJ , ESMOLOL HCL 10MG/ML INJ , ETOPOSIDE 20MG/ML INJ,VIL,25ML , ETOPOSIDE 20MG/ML INJ,VIL,50ML , ETOPOSIDE 20MG/ML INJ,VIL,5ML , FAMOTIDINE 10MG/ML INJ , FAMOTIDINE 40MG/4ML SUSP,ORAL , FISH OIL EMULSION 0.1G/ML INJ, 100ML , FISH OIL EMULSION 0.1G/ML INJ, 50ML , FLOXURIDINE 500MG/VIL INJ , FLUDARABINE PO4 50MG/VIL INJ , FLUMAZENIL 0.1MG/ML INJ , FLUOROURACIL 100MG/ML INJ , FLUOROURACIL 50MG/ML INJ , FLUPHENAZINE DECANOATE 25MG/ML INJ , FLUPHENAZINE HCL 2.5MG/ML INJ , FOLIC ACID 5MG/ML INJ , FOSAPREPITANT DIMEGLUMINE 150MG/VIL INJ , FOSPHENYTOIN NA 50MG-PE/ML INJ , FULVESTRANT 50MG/ML INJ,SYRINGE,5ML , FUROSEMIDE 100MG/10ML INJ , FUROSEMIDE 10MG/ML INJ , FUROSEMIDE 40MG/5ML INJ , GANCICLOVIR 500MG/VIL INJ , GEMCITABINE HCL 2GM/VIL INJ , GENTAMICIN SO4 10MG/ML (PF) INJ , GENTAMICIN SO4 40MG/ML INJ , GENTAMICIN SO4 80MG/VIL INJ , GLUCAGON 1MG/VIL INJ , GLUCAGON 1MG/VIL INJ,EMERGENCY KIT , GLUCAGON FOR INJ POWDER 1MG/3ML , GLYCOPYRROLATE 0.2MG/ML INJ , GLYCOPYRROLATE 0.2MG/ML INJ,SYRINGE,1ML , GLYCOPYRROLATE 0.2MG/ML INJ,SYRINGE,2ML , GRANISETRON HCL 1 MG/ML VIAL , GRANISETRON HCL 1MG/ML INJ,4ML VIL , HALOPERIDOL 5MG/ML INJ , HALOPERIDOL DECANOTE 100MG/ML INJ , HALOPERIDOL DECANOTE 250MG/5ML INJ , HALOPERIDOL DECANOTE 500MG/5ML INJ , HALOPERIDOL DECANOTE 50MG/ML INJ , HEPARIN NA (PORK) 1000UNT/ML INJ , HEPARIN NA (PORK) 20000UNT/ML INJ , HEPARIN NA (PORK) 5000UNT/ML INJ , HEPARIN NA 10000UNT/ML INJ , HEPARIN NA 1000UNT/ML (PF) INJ , HEPARIN NA 1000UNT/ML INJ , HEPARIN NA 5000 UNT/0.5ML SYRINGE,0.5ML , HEPARIN NA 5000UNT/0.5/ML INJ , HEPARIN NA 5000UNT/ML INJ , HYDRALAZINE HCL 20MG/ML INJ , HYDROMORPHONE 0.5MG/0.5ML INJ,SYRINGE,0.5ML , HYDROMORPHONE 1MG/ML INJ,SYRINGE,0.5ML , HYDROMORPHONE HCL 0.2MG/ML INJ , HYDROMORPHONE HCL 10MG/ML INJ , HYDROMORPHONE HCL 1MG/ML INJ , HYDROMORPHONE HCL 1MG/ML INJ,1ML , HYDROMORPHONE HCL 2MG/ML INJ , HYDROMORPHONE HCL 2MG/ML INJ,1ML , HYDROMORPHONE HCL 4MG/ML INJ , IFOSFAMIDE 1GM/VIL INJ , INDOMETHACIN NA 1MG/VIL INJ , IRINOTECAN HCL 20MG/ML INJ,SOLN , KABIVEN 1310KCAL /1540ML INFU, LIQ , KABIVEN 1745KCAL /2053ML INFU, LIQ , KABIVEN INF LIQ 2180KCAL , KABIVEN INF LIQ 870KCAL , KETOROLAC TROMETHAMINE 15MG/ML INJ , KETOROLAC TROMETHAMINE 15MG/ML INJ,SYRINGE,1ML , KETOROLAC TROMETHAMINE 30MG/ML INJ , KETOROLAC TROMETHAMINE 30MG/ML INJ,SYRINGE,1ML , KETOROLAC TROMETHAMINE 30MG/ML INJ,SYRINGE,2ML , LACTATED RINGER'S INJ , LEUCOVORIN CALCIUM (CALCIUM FOLINATE 10MG/ML INJ) , LEUCOVORIN CALCIUM 200MG/50ML VIL INJ , LEUCOVORIN CALCIUM 500MG/100ML VIL INJ , LEVETIRACETAM 500MG/5ML INJ , LEVOFLOXACIN/DEXTROSE 250MG/50ML, INJ,BAG,50ML , LEVOFLOXACIN/DEXTROSE 500MG/100ML, INJ,BAG,50ML , LEVOFLOXACIN/DEXTROSE 750MG/150ML,INJ,BAG,150ML , LEVOTHYROXINE NA 100MCG/VIL INJ , LEVOTHYROXINE NA 200MCG/VIL INJ , LEVOTHYROXINE NA 500MCG/VIL INJ , LIDOCAINE HCL 0.5% (PF) INJ , LIDOCAINE HCL 0.5% INJ , LIDOCAINE HCL 1% (PF) INJ , LIDOCAINE HCL 1% INJ , LIDOCAINE HCL 1%/EPINEPHRINE 1:100000 INJ , LIDOCAINE HCL 1%/EPINEPHRINE 1:200000 INJ , LIDOCAINE HCL 1.5% (PF) INJ , LIDOCAINE HCL 1.5% INJ , LIDOCAINE HCL 1.5%/EPINEPHRINE 1:200000 INJ , LIDOCAINE HCL 2% INJ , LIDOCAINE HCL 2%/EPINEPHRINE 1:100000 INJ , LIDOCAINE HCL 2%/EPINEPHRINE 1:200000 INJ , LIDOCAINE HCL 20MG/ML (PF) INJ , LINEZOLID 2MG/ML INJ,BAG,300ML , MAGNESIUM SO4 10G/20ML INJ , MAGNESIUM SO4 1GM/100ML INJ,BAG , MAGNESIUM SO4 20GM/500ML INJ/BAG , MAGNESIUM SO4 25GM/50ML INJ , MAGNESIUM SO4 2GM/50ML INJ,BAG , MAGNESIUM SO4 40GM/1000ML INJ,BAG , MAGNESIUM SO4 4GM/100ML INJ,BAG , MAGNESIUM SO4 4GM/50ML INJ,BAG , MAGNESIUM SO4 4MEQ/ML (PF) INJ , MANNITOL 250MG/ML INJ , MELPHALAN HCL 50MG/VIL INJ , MEPIVACAINE HCL 1% INJ , MEPIVACAINE HCL 1.5% INJ , MEPIVACAINE HCL 2% INJ , MEROPENEM 1GM/VIL,INJ , MEROPENEM 500MG/VIL,INJ , MESNA 100MG/ML INJ , METHOTREXATE NA 1GM/VIL INJ , METHOTREXATE NA 250MG/VIL INJ , METHYLPREDNISOLONE NA SUCCINATE 1000MG/VIL INJ , METHYLPREDNISOLONE NA SUCCINATE 125MG/VIL INJ , METHYLPREDNISOLONE NA SUCCINATE 40MG/VIL INJ , METOCLOPRAMIDE HCL 5MG/ML INJ , METOPROLOL TARTRATE 5MG/ML INJ , MIDAZOLAM HCL 1MG/ML (PF) INJ , MIDAZOLAM HCL 1MG/ML INJ , MIDAZOLAM HCL 5MG/ML (PF) INJ , MIDAZOLAM HCL 5MG/ML INJ , MILRINONE LACTATE 1MG/ML INJ , MITOXANTRONE HCL 2MG/ML INJ , MORPHINE SO4 10MG/ML INJ , MORPHINE SO4 2MG/ML INJ , MORPHINE SO4 4MG/ML INJ , MORPHINE SO4 5MG/ML INJ , MORPHINE SO4 8MG/ML INJ , MOXIFLOXACIN HCL 1.6MG/ML/NACL INJ,BAG,250ML , NAFCILLIN NA 10GM/VIL INJ , NAFCILLIN NA 1GM/VIL INJ , NAFCILLIN NA 2GM/VIL INJ , NEOSTIGMINE METHYLSULFATE 0.5MG/ML INJ , NEOSTIGMINE METHYLSULFATE 1MG/ML INJ , NEOSTIGMINE METHYLSULFATE 1MG/ML INJ,SYR,3ML , OCTREOTIDE ACETATE 0.1MG/ML INJ , OCTREOTIDE ACETATE 0.2MG/ML INJ , OCTREOTIDE ACETATE 0.5MG/ML INJ , OCTREOTIDE ACETATE 1MG/ML INJ , ONDANSETRON HCL 2MG/ML (PF) INJ,SYRINGE,2ML , ONDANSETRON HCL 2MG/ML INJ,SOLN , OXYTOCIN 10UNT/ML INJ , PALONOSETRON HCL 50MCG/ML INJ,5ML , PALONOSETRON HCL 50MCG/ML INJ,SYRINGE,5ML , PENTAMIDINE ISETHIONATE 300MG/VIL INJ , PENTAMIDINE ISETHIONATE 300MG/VIL SOLN,INHL , PERI KABIVEN INF LIQ 1620KCAL , PERI KABIVEN INF LIQ 970KCAL , PERI KABIVEN INF LIQUID 1300KCAL/1920ML , PHENYLEPHRINE HCL 10MG/ML INJ , PHOSPHORUS 3MMOL/POTASSIUM 4.4MEQ/ML (PF) INJ , PIPERACILLIN NA 2.25GM/TAZOBACTAM NA 0.25GM/VIL INJ , PIPERACILLIN NA 3GM/TAZOBACTAM NA 0.375GM/VIL INJ , PIPERACILLIN NA 4.5GM/TAZOBACTAM NA 0.25GM/VIL INJ , PIPERACILLIN NA 40.5GM/TAZOBACTAM NA 0.25GM/VIL INJ , POTASSIUM CHLORIDE 2MEQ/ML INJ , PROGESTERONE 50MG/ML (IN OIL) INJ,SOLN , PROPOFOL 10MG/ML INJ,EMULSION , PROPRANOLOL HCL 1MG/ML INJ , PROTAMINE SO4 10MG/ML INJ , PYRIDOXINE HCL 100MG/ML INJ , REMIFENTANIL HCL 1MG/VIL INJ , REMIFENTANIL HCL 2MG/VIL INJ , REMIFENTANIL HCL 5MG/VIL INJ , RIFAMPIN 600MG/VIL INJ , ROCURONIUM BR 10MG/ML INJ,10ML VIL , ROCURONIUM BR 10MG/ML INJ,5ML VIL , ROPIVACAINE HCL 0.2% INJ,AMP,10ML , ROPIVACAINE HCL 0.2% INJ,AMP,20ML , ROPIVACAINE HCL 0.2% INJ,BAG,100ML , ROPIVACAINE HCL 0.2% INJ,BAG,200ML , ROPIVACAINE HCL 0.2% INJ,BTL,100ML , ROPIVACAINE HCL 0.2% INJ,BTL,200ML , ROPIVACAINE HCL 0.5% INJ,AMP,20ML , ROPIVACAINE HCL 0.5% INJ,STERILE-PAK,30ML , ROPIVACAINE HCL 0.5% INJ,VIL,30ML , ROPIVACAINE HCL 0.75% INJ,AMP,20ML , ROPIVACAINE HCL 0.75% INJ,VIL,20ML , ROPIVACAINE HCL 1% INJ,AMP,10ML , ROPIVACAINE HCL 1% INJ,AMP,20ML , ROPIVACAINE HCL 1% INJ,VIL,10ML , ROPIVACAINE HCL 100MG/20ML INJ , ROPIVACAINE HCL 2% INJ,VIL,20ML , ROPIVACAINE HCL 20MG/VIL INJ , ROPIVACAINE HCL 40MG/20ML INJ , SMOFLIPID 100GM/500ML INJ , SMOFLIPID 200GM/1000ML INJ , SMOFLIPID 20GM/100ML INJ , SMOFLIPID 50GM/250ML INJ , SODIUM ACETATE 4MEQ/ML (PF) INJ , SODIUM CHLORIDE 0.45% INJ , SODIUM CHLORIDE 0.9% INJ , SODIUM CHLORIDE 0.9% INJ,BAG,1000ML , SODIUM CHLORIDE 0.9% INJ,BAG,100ML , SODIUM CHLORIDE 0.9% INJ,BAG,250ML , SODIUM CHLORIDE 0.9% INJ,BAG,500ML , SODIUM CHLORIDE 0.9% INJ,BAG,50ML , SODIUM CHLORIDE 0.9%/BENZYL ALCOHOL INJ,30ML , SODIUM CHLORIDE 120MEQ/30ML VIL, INJ , SODIUM CHLORIDE 23.4% (PF) INJ,CONC , SUMATRIPTAN SUCCINATE 6MG/0.5ML INJ,VIL,0.5ML , TERBUTALINE SO4 1MG/ML INJ , THIAMINE HCL 100MG/ML INJ , TIGECYCLINE 50MG/VIL INJ , TOBRAMYCIN SO4 1.2GM/VIL INJ , TOBRAMYCIN SO4 10MG/ML INJ , TOBRAMYCIN SO4 40MG/ML INJ , TOPOTECAN HCL 4MG/VIL INJ , TRANEXAMIC ACID 100MG/ML INJ,VIL,10ML , VALPROATE NA 100MG/ML INJ , VANCOMYCIN HCL 10GM/VIL INJ , VANCOMYCIN HCL 5GM/VIL INJ , VANCOMYCIN HCL 750MG/VIL INJ , VINBLASTINE SO4 1MG/ML INJ , WATER FOR INJECTION , WATER FOR INJECTION, STERILE , WATER FOR INJECTION,STERILE,50ML , CALCIUM ACETATE 667MG (CA 169MG) CAP , CALCIUM ACETATE 667MG/5ML SOL , SUCROFERRIC OXYHYDROXIDE 500MG TAB,CHEW

FDA Production Site Inspection Outcomes since 2019

10 / 3

2019 / 2020 Inspections
No Action Indicated:
Fresenius Kabi USA, LLC - Melrose Park - IL - US - 2019-03-08
Fresenius Kabi USA LLC - Skokie - IL - US - 2020-03-05
Fresenius Medical Care Holdings, Inc. dba Fresenius Medical Care North America - Knoxville - TN - US - 2019-09-12
SGS Institut Fresenius Berlin GmbH & Co. KG - Berlin - - DE - 2019-06-17
SGS Institut Fresenius GmbH - Taunusstein - - DE - 2019-09-18

Voluntary Action Indicated:
Fresenius Kabi USA, LLC - Wilson - NC - US - 2019-02-05
Fresenius Medical Care, North America - Ogden - UT - US - 2020-08-13
Fresenius Medical Care Holdings, Inc. dba Fresenius Medical Care North America - Knoxville - TN - US - 2020-06-26
Fresenius Medical Care Holdings, Inc. - Waltham - MA - US - 2019-08-02
Fresenius Kabi USA, LLC - Grand Island - NY - US - 2019-08-12
Fresenius Kabi Austria GmbH - Graz - - AT - 2019-02-08
Fresenius Kabi Norge As - Halden - - NO - 2019-09-03
Fresenius Kabi iPSUM Srl - Villadose - - IT - 2019-12-06

Official Action Indicated:

Recent FDA Recalls (Abridged)

7

Recent Recalls
Fresenius - 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
14,016 vials, 20190724

Fresenius - Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20 - Failed Impurities/Degradation Specifications.
11,981 units, 20190619

Fresenius - Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451 - CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
32,592 bags, 20200325

Fresenius - Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Single Dose Vials per tray (NDC 63323-162-02); For IM use only, Not for IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047. - Presence of Particulate Matter - found in reserve sample vials at the firm.
3,497,575 vials, 20200617

Fresenius - Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047. - Presence of Particulate Matter - found in reserve sample vials at the firm.
5,314,400 vials, 20200617

Fresenius - Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10 - Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.
63,067 vials, 20200722

Fresenius - Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 63323-671-50 - Cross Contamination with other products: trace amounts of lidocaine
25,100 bottles, 20200902

One Search.

1. Search by Drug:

Enter atleast 4 letters

2. Search by Company:

Enter alteast 4 letters