Aurobindo Pharma’s US arm is recalling 47,040 bottles of Venlafaxine Hydrochloride extended release capsules, manufactured by the Hyderabad-based firm, from the American market. Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder.
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. 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. According the FDA, 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.