Indian generics maker Sun Pharmaceutical is voluntarily recalling 41,127 bottles of the antidepressant venlafaxine HCl extended-release tablets over improper dissolution.
Sun’s U.S. subsidiary, Caraco Pharmaceutical Laboratories, initiated the Class II recall June 6. Recalled were 26,530 bottles of venlafaxine 150 mg in 30-count containers and 14,597 bottles of 90-count, according to the FDA enforcement report. The tablets were made in India and distributed by Caraco.
The recall was precipitated by stability test results that showed the generic version of Wyeth’s Effexor XR failed to meet dissolution requirements, the FDA said.
This is not Sun’s first quality problem with venlafaxine. In May, the manufacturer recalled more than 215,882 bottles of venlafaxine HCl for the same reason, along with 176,176 bottles of the generic antihistamine cetirizine HCl.
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