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Glenmark recalls three drugs from US market

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Hyderabad:

Glenmark Generics, a subsidiary of Glenmark Pharmaceuticals, is recalling multiple lots of three of its drugs from the US market due to "odd smell", according to US Food and Drug Administration.

A notification issued by US Food and Drug Administration said that the drug major has initiated voluntary recall of its Gabapentin Tablets 600mg, 500-count bottle and 800 mg, 500-count bottle; Pravastatin Sodium Tablets 40 mg, 90-count bottle; and Topiramate Tablets 200 mg, 60-count bottles from the US market following the identification of the problem.

Glenmark has initiated the recall due to complaints related to an off-odour described as moldy, musty or fishy in nature, the notification said.

The firm has been recalling 33,138 bottles and 9,278 bottles of Gabapentin Tablets 600mg and 800 mg, respectively, 246,528 bottles of Pravastatin and 9624 bottles of Topiramate Tablets, it said.

When contacted, Glenmark spokesperson said the problem is due to bottle supplier whose services have been terminated.

"This is a voluntary recall initiated by the company. 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...We have assured that there is no longer any material (drug bottles) in our New Jersey distribution centre at this time packaged in HDPE bottles supplied by that one manufacturer. The recalls have insignificant financial implications," the spokesperson told PTI in an email reply.

Glenmark Pharmaceuticals received US FDA approval to market Gabapentin oral tablets 600 mg and 800 mg in 2006 and the drug belongs to a category of anti-convulsants and is prescribed to help control epileptic seizures.

It is also widely used to relieve different kinds of pain and even psychiatric disorders.

The Indian drug maker received approval in the US to market a generic version of Bristol Myers Squibb's cholesterol lowering drug, Pravachol (10 mg, 20 mg and 40 mg), known under its generic name as pravastatin sodium in 2007.

Similarly, it received tentative approval from the US FDA for its abbreviated new drug application (ANDA) for Topiramate Tablets in multiple strengths (25 mg, 50 mg, 100 mg and 200 mg) in 2007.

The recall of the three drugs was initiated under Class-III which FDA defined as "a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences".

It may be mentioned that Glenmark in February had said it initiated recalling multiple lots of its Montelukast Sodium Tablets, 10 mg packaged in 30 and 90 count tablets per bottle from the US market due to similar "off-odour" complaints complaints.


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