Trade Resources Industry Views Glenmark Generics Is Recalling Gabapentin, Pravastatin and Topiramate Drugs

Glenmark Generics Is Recalling Gabapentin, Pravastatin and Topiramate Drugs

Glenmark Generics, a subsidiary of Glenmark Pharmaceuticals, is recalling several lots of Gabapentin, Pravastatin, and Topiramate drugs from across the US markets primarily due to “odd smell.”

The US Food and Drug Administration was cited by the Press Trust of India as saying that the company has already initiated a voluntary recall.

The drugs include 33,138 bottles of Gabapentin Tablets 600mg, 9,278 bottles of Gabapentin 800 mg, 246,528 bottles of Pravastatin, and 9624 bottles of Topiramate tablets.

Citing insignificant financial implications of these recalls, a company spokesperson said, "All recalls pertain to off-odour complaints from bottles supplied by one HDPE bottle supplier whose services are not being used by the company anymore."

Glenmark Generics has structured its businesses as US Generics, European Generics, the active pharmaceutical ingredient (API) business, and the oncology business.

The company had recalled many lots of Montelukast Sodium Tablets, 10 mg packaged in 30 and 90 count tablets per bottle in February 2013 from the US market, due to similar reasons. 

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/glenmark-generics-recalls-three-drugs-from-us-270513
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Glenmark Generics Recalls Three Drugs From US