FDA recall D-329-2013

Glenmark Generics Inc., USA · Class III · drug

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 Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India, Manufactured for : Glenmark Generics USA Mahwah, NJ 07430.

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

Key facts

Status: Terminated
Initiation date: 2013-04-05
Report date: 2013-05-22
Termination date: 2014-10-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mahwah, NJ, United States

Primary source

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