Zydus Cadila is recalling over 2 lakh bottles of anti-depressant Venlafaxine HCL ER capsules in the US in two different strengths for failed dissolution specifications.
According to information available on the United States Food and Drug Administration (USFDA) site, Zydus Pharmaceuticals USA is recalling drugs manufactured by the Ahmedabad-based Cadila Healthcare.
The recall for 150 mg Venlafaxine HCL ER capsule USP is for 2,23,776 bottles, but the US health regulator did not specify the quantity of the recall of 75 mg capsules.
Venlafaxine HCL ER capsule is used for treatment of major depressive and anxiety disorders.
The ongoing voluntary nation-wide recalls are on account of “out of specification dissolution results in retained samples”, the United States Food and Drug Administration (USFDA) said in the latest Enforcement Report.
The recall is a class II recall, the regulator 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”.