AurobindoPharma is recalling 47,040 bottles of Venlafaxine Hydrochloride extended release capsules, manufactured by the Hyderabad-based firm, from the American market.
Aurobindo Pharma USA Inc is recalling 47,040 bottles of Venlafaxine Hydrochloride extended release capsules in the strength of 37.5 mg in a nationwide recall in the US, latest Enforcement Report of the USFDA has said.
The drug was manufactured by Aurobindo Pharma Ltd, Hyderabad, it added.
As per the United States Food and Drug Administration (USFDA) the recall is on account of “failed tablet/capsule specifications: some bottles contain punctured, and/or clumped /melted capsules”.
The voluntary ongoing recall is a Class II recall, it added.
According the FDA, a class II recall is initated 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”.
Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder.