New Delhi, July 19, 2014 –
Sun Pharma’s US subsidiary Caraco Pharmaceutical Laboratories has initiated recall for Venlafaxine Hydrochloride extended-release tablets manufactured in the company’s Indian facility. The recall of 26,530 units of 30-count bottles and 14,597 units of 90-count bottles is voluntarily initiated by the company as per the FDA notification. Venlafaxine Hydrochloride is part of the serotonin-norepinephrine reuptake inhibitor (SNRI) class of medicines that are used for the treatment of major depressive disorder, generalized anxiety disorder, social anxiety disorder and panic disorder.
The FDA classified the recall as class II, meaning that this is a situation in which use of or exposure to a violativeproduct may cause temporary or medically reversible adverse health consequences. However, the probability of serious adverse health consequences is remote compared to class I.The recalled drug bottles were distributed by Caraco Pharmaceutical Laboratories Ltd in USA, while they were manufactured at Halol plant in Gujarat by Sun Pharmaceutical Industries Ltd. It was recalled for failing a dissolution test according to the US Food and Drug Administration. FDA said, “Stability results found the product did not meet the drug release dissolution specifications.” Tablet dissolution is a standardized method for measuring the rate of drug release from a dosage form.
Sun Pharma’s product venlafaxine hydrochloride is a generic version of Pfizer’s Effexor XR which was also recalled earlier after a pharmacist reported that one of the bottles contained a heart drug. Sun Pharma also recalled 200 vials of the chemotherapy drug gemcitabine in the United States in April due to a lack of assurance of sterility. IGMPI
