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 and manic episodes in people with bipolar disorder , latest Enforcement Report of the USFDA said.
The tablets were manufactured by Ahmedabad-based Cadila Healthcare and are being recalled on account of failed dissolution specifications, the report said.
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.
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". – The Economic Times