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Zydus Pharma recalls 3.31 lakh bottles of seizure drug in US

Press Trust of India  |  New Delhi 

Zydus Pharmaceuticals Inc is recalling from the US market over 3.31 lakh bottles of Divalproex Sodium delayed release tablets used for treatment of seizures and manic episodes in people with bipolar disorder , latest Enforcement Report of the USFDA said.

The tablets were manufactured by Ahmedabad-based and are being recalled on account of failed dissolution specifications, the report said.

Zydus Pharmaceuticals is voluntarily recalling 1,08,096 High-density polyethylene (HDPE) bottles of Divalproex Sodium delayed release tablets, USP, 125 mg, it added.

The company is also recalling 1,15,122 HDPE bottles in the strength of 250 mg and 1,08,726 HDPE bottles in the strength of 500 mg, it added.

The reason for the voluntary ongoing nationwide recall is 'Failed Dissolution Specifications', the USFDA said. The recalls are of class II, it said.

As per the USFDA, a class II recall is initiated in a situation "in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote".

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Thu, August 10 2017. 17:07 IST