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Recall Enforment Report D-330-2013

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Glenmark Generics Inc., USA, originally initiated on 04-05-2013 for the product Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for :Glenmark Generics USA Mahwah, NJ 07430 The product was recalled due to chemical contamination: pravastatin sodium tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-330-201304-05-201305-22-2013Class III246,528 bottlesGlenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for :Glenmark Generics USA Mahwah, NJ 07430Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.Terminated
D-329-201304-05-201305-22-2013Class IIIa) 33,138 bottles (500ct) ; b)19,278 bottles (500 ct)Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b) 800 mg, 500- count bottle (NDC 68462-127-05), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India, Manufactured for : Glenmark Generics USA Mahwah, NJ 07430.Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.Terminated
D-331-201304-05-201305-22-2013Class III9624 bottlesGlenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for : Glenmark Generics USA Mahwah, NJ 07430Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
68462-108Topiramate TopiramateTablet, Film CoatedOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-109Topiramate TopiramateTablet, Film CoatedOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-110Topiramate TopiramateTablet, Film CoatedOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-126Gabapentin GabapentinTabletOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-127Gabapentin GabapentinTabletOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-153Topiramate TopiramateTablet, Film CoatedOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-195Pravastatin Sodium Pravastatin SodiumTabletOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-196Pravastatin Sodium Pravastatin SodiumTabletOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-197Pravastatin Sodium Pravastatin SodiumTabletOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-198Pravastatin Sodium Pravastatin SodiumTabletOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug