Voluntary Glenmark Recall Issued for Three Drugs: Gabapentin, Pravastatin Sodium and Topiramate-is

glenmark recallGlenmark Generics Inc., a subsidiary of Glenmark Pharmaceuticals announced a recall for three of their products last April 2013. The recalls are shown on the enforcement report found in the United Sates Food and Drug Administration website (US FDA) on the week of May 22, 2013.

The drugs included in the Glenmark recall were Gabapentin (600mg and 800mg), Pravastatin Sodium (40mg), and Topiramate (200mg) tablets. The recall is still ongoing since a lot of these products were distributed in the market. Specifically, 246,528 bottles of Pravastatin Sodium, 9624 bottles of Topiramate, and a total of 52,416 bottles for Gabapentin are being recalled (US FDA, 2013).

What are Gabapentin, Pravastatin Sodium, and Topiramate?

Gabapentin is an anti-convulsant used mainly by patients who have epileptic seizures and in order to relieve the pain brought about by postherpetic neuralgia (a nerve pain thought to be caused by shingles from infection with varicella zoster virus) (Medline Plus 2011). Gabapentin is also used for different kinds of pain and sometimes, psychiatric disorders.

Like Gabapentin, Topiramate is also used (alone or combined with other meds) in people who have epileptic seizures or those with Lennox-Gastaut syndrome (a childhood-onset epilepsy accompanied by seizures, developmental delays, and behavioral problems).

Pravastatin is used to lower blood cholesterol and triglycerides found in the blood. It is also prescribed to people who have a high risk of developing a heart disease and/or stroke in order to lower their risk provided they combine it with diet and exercise (Medline Plus 2013).

What was the cause for the Glenmark recall?

The Glenmark recall was caused by complaints from consumers related to a chemical contamination which is the presence of an off-odor that is “moldy, musty or fishy in nature” (US FDA, 2013). The FDA classified the recall under Class 3 which means that “exposure to the violative product is not likely to cause adverse health consequences” (US FDA 2009). Still, the Glenmark recall was voluntary and firm initiated based on the US FDA reports.

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