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Sun Pharmaceutical’s subsidiary Caraco Pharmaceutical Laboratories recalled some lots of venlafaxine hydrochloride extended-release tablets from the US market after the product failed to meet certain specifications.
According to a notification by the US Food and Drug Administration, the recall of 26,530 units of 30-count bottles and 14,597 units of 90-count bottles was voluntarily initiated through a letter to the regulator last month under a Class-II classification. It is used for major depressive disorder.
"Stability results found the product did not meet the drug release dissolution specifications," US FDA said in its notification.
Tablet dissolution is a standardised method for measuring the rate of drug release from a dosage form.
The recalled drug bottles were distributed by Caraco Pharmaceutical Laboratories Ltd in USA, while manufactured at Halol plant in Gujarat by Sun Pharmaceutical Industries.
A class II recall is a situation in which the 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.
