Reported May 22, 2013 · Terminated
Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b) 800 mg, 500- count bottle (NDC…
Glenmark Generics Inc., USA
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Glenmark Generics Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009
Is this the product you have?
- 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 forGlenmark Generics USA Mahwah, NJ 07430
- Lot codes and dates
25 of 25 products
Products covered by this recall # Product as published 1 Lot# 02123419, Exp 10/14 2 Lot# 02123424, Exp 10/14 3 Lot# 02123430, Exp 10/14 4 Lot# 02123492, Exp 10/14 5 Lot# 02123523, Exp 10/14 6 Lot# 02123527, Exp 10/14 7 Lot# 02123532, Exp 10/14 8 Lot# 02123542, Exp 10/14 9 Lot# 02123546, Exp 10/14 10 Lot# 02123551, Exp 10/14 11 Lot# 02123555, Exp 10/14 12 Lot# 02123560, Exp 11/14 13 Lot# 02123566, Exp 11/14 14 Lot# 02123569, Exp 11/14 b) 800 mg 15 Lot# 02123440 Exp 10/14 16 Lot# 02123445 Exp 10/14 17 Lot# 02123454 Exp 10/14 18 Lot# 02123465 Exp 10/14 19 Lot# 02123789 Exp 11/14 20 Lot# 02123804 Exp 11/14 - Amount recalled
- a) 33,138 bottles (500ct) ; b)19,278 bottles (500 ct)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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