FDAClass IIIMay 22, 2013

Glenmark Gabapentin Tablets recall: Contamination

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…

Why was Glenmark Gabapentin Tablets recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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
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…
Recalling firm
Glenmark Generics Inc., USA
Quantity
a) 33,138 bottles (500ct) ; b)19,278 bottles (500 ct)
Distribution
Nationwide
Recall date
May 22, 2013
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls