Zydus Pharma recalls 3.31 lakh bottles of seizure drug in US

Zydus Pharmaceuticals USA Inc is recalling from the US market over 3.31 lakh bottles of Divalproex Sodium delayed release tablets used for treatment of seizures.

The tablets were manufactured by Ahmedabad-based Cadila Healthcare and are being recalled on account of failed dissolution specifications.

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

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”.

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