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FDA (Drug enforcement)Recalled 2013-04-05closedclass iii

Glenmark Generics Inc., USA: 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 Lt

Is my product affected?

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.

  • Brand GABAPENTIN

Check against the official notice below — it lists the full affected range.

What happened

Glenmark Generics Inc. is recalling Gabapentin tablets in two strengths: 600mg (33,138 bottles of 500 tablets) and 800mg (19,278 bottles of 500 tablets) distributed nationwide. The recall was initiated due to complaints about an off-odor in the tablets described as moldy, musty, or fishy. The affected products include multiple lot numbers of both strengths, with expiration dates ranging from October 2014 to November 2014.

The record does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.

Details from the source

Reason for recall: Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature. Distribution: Nationwide Quantity: a) 33,138 bottles (500ct) ; b)19,278 bottles (500 ct) Lot/code info: a) 600mg: Lot# 02123419, Exp 10/14 Lot# 02123424, Exp 10/14 Lot# 02123430, Exp 10/14 Lot# 02123492, Exp 10/14 Lot# 02123523, Exp 10/14 Lot# 02123527, Exp 10/14 Lot# 02123532, Exp 10/14 Lot# 02123542, Exp 10/14 Lot# 02123546, Exp 10/14 Lot# 02123551, Exp 10/14 Lot# 02123555, Exp 10/14 Lot# 02123560, Exp 11/14 Lot# 02123566, Exp 11/14 Lot# 02123569, Exp 11/14 b) 800 mg Lot# 02123440 Exp 10/14 Lot# 02123445 Exp 10/14 Lot# 02123454 Exp 10/14 Lot# 02123465 Exp 10/14 Lot# 02123789 Exp 11/14 Lot# 02123804 Exp 11/14 Lot# 02123821 Exp 11/14 Lot# 02123829 Exp 11/14 Lot# 02123834 Exp 11/14 Lot# 02123841 Exp 11/14 Lot# 02123845 Exp 11/14

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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