Product Detail

Product Description
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.

Recall Number D-329-2013

Classification Class III

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

Product Distributed Qty a) 33,138 bottles (500ct) ; b)19,278 bottles (500 ct)

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.

Event Detail

Event Id 64995

Product Type Drugs

Status Ongoing

Recalling Firm Glenmark Generics Inc., USA, Mahwah, NJ, USA

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-04-05

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide