Aurobindo Pharma USA Inc. recalls 47,040 bottles of Venlafaxine hydrochloride prolonged-release capsules in the 37.5 mg strength in a national recall in the US, the latest USFDA enforcement report said. The drug was manufactured by Aurobindo Pharma Ltd, Hyderabad
Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder
According to the FDA, a class II recall is initiated in "a situation in which the use or exposure to a violent product may cause temporary or medically reversible adverse health effects or where the likelihood of serious health consequences”. The voluntary ongoing recall is a Class II recal
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".
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