FDA-Drug2013-05-22Class III

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.

Glenmark Generics Inc., USA
Hazard

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

Sold states
Nationwide
Affected count
a) 33,138 bottles (500ct) ; b)19,278 bottles (500 ct)
Manufactured in
750 Corporate Dr, Mahwah, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-329-2013

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