Caraco Pharmaceutical Laboratories, the US arm of Sun Pharma, is withdrawing two lots of the drug as "stability results found the product did not meet the drug release dissolution specifications," according to information on the US Food and Drug Administration website.
The company is recalling 1,60,105 bottles of Venlafaxine Hydrochloride extended release tablets of 150 mg strength and 91,777 bottles of 37.5 mg strength in the US market. Caraco initiated the nationwide recall on March 20.
According to the US health regulator, the recall falls under Class II, in which the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote.
The drugs were manufactured at Sun Pharma's Halol manufacturing facility in Gujarat.
When contacted, a Sun Pharma spokesperson declined to comment.
Sun Pharma shares declined 1.07 per cent to Rs 624.70 at the close on the BSE Sensex