Recall Enforment Report D-0827-2021

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Glenmark Pharmaceuticals Inc., USA, originally initiated on 08-27-2021 for the product Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 60x2 mL Sterile Unit-Dose Vials NDC 68462-833-65; b) 30x2 mL Sterile Unit-Dose Vials NDC 68462-833-35 The product was recalled due to lack of assurance of sterility. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0827-202108-27-202109-29-2021Class IIa) 5362 inhalers; b) 5593 inhalersArformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 60x2 mL Sterile Unit-Dose Vials NDC 68462-833-65; b) 30x2 mL Sterile Unit-Dose Vials NDC 68462-833-35Lack of Assurance of SterilityOngoing
D-0820-202108-27-202109-29-2021Class II28658 cartonsFulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32Lack of Assurance of SterilityOngoing
D-0825-202108-27-202109-29-2021Class II15936 bottlesZonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430CGMP DeviationsOngoing
D-0826-202108-27-202109-29-2021Class IIa) 216,454 bottles; b) 2166 bottlesZonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Capsules NDC 68462-130-01; b) 500 Capsules NDC 68462-130-05CGMP DeviationsOngoing
D-0824-202108-27-202109-29-2021Class II4752 bottlesChlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430CGMP DeviationsOngoing
D-0823-202108-27-202109-29-2021Class II1800 bottlesChlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430CGMP DeviationsOngoing
D-0821-202108-27-202109-29-2021Class II9552 bottlesNaproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430CGMP DeviationsOngoing
D-0822-202108-27-202109-29-2021Class IIa) 31248 bottles; b) 300 bottlesNaproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Tablets NDC 68462-179-01; b) 500 Tablets NDC 68462-179-05CGMP DeviationsOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
68462-128Zonisamide ZonisamideCapsuleOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-129Zonisamide ZonisamideCapsuleOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-130Zonisamide ZonisamideCapsuleOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-178Naproxen Sodium Naproxen SodiumTabletOralGlenmark Pharmaceuticals Limited Inc., UsaHuman Prescription Drug
68462-179Naproxen Sodium Naproxen SodiumTabletOralGlenmark Pharmaceuticals Limited Inc., UsaHuman Prescription Drug
68462-188Naproxen NaproxenTabletOralGlenmark Pharmaceuticals Limited Inc., UsaHuman Prescription Drug
68462-189Naproxen NaproxenTabletOralGlenmark Pharmaceuticals Limited Inc., UsaHuman Prescription Drug
68462-190Naproxen NaproxenTabletOralGlenmark Pharmaceuticals Limited Inc., UsaHuman Prescription Drug
68462-317Fulvestrant FulvestrantInjectionIntramuscularGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-724Chlorzoxazone ChlorzoxazoneTabletOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-725Chlorzoxazone ChlorzoxazoneTabletOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-833Arformoterol Tartrate Arformoterol TartrateSolutionRespiratory (inhalation)Glenmark Pharmaceuticals Inc., UsaHuman Prescription Drug