Sun Pharmaceuticals Industries Ltd. said its subsidiary Caraco Pharmaceutical Laboratories had initiated voluntary recall of some lots of Venlafaxine Hydrochloride extended-release from the US market, reports said, quoting US FDA.
As per the FDA notification, the recall of 26,530 units of 30-count bottles and 14,597 units of 90-count bottles is voluntarily initiated by the company through a letter to the regulator last month under 'Class-II' classification.
Venlafaxine Hydrochloride extended-release tablets are indicated for the treatment of major depressive disorder.
"Stability results found the product did not meet the drug release dissolution specifications," FDA said.
Stability results found that the product did not meet the drug release dissolution specifications, FDA said. dissolution is a standardized method for measuring the rate of drug release from a dosage form.
The recalled drug bottles were distributed by Caraco Pharmaceutical Laboratories in USA, .while manufactured at Halol plant in Gujarat by Sun Pharma.
As per US health regulator, 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.
At the BSE, Sun Pharmaceutical shares are currently trading at Rs.735.90, up 1.51 percent from the previous close.