India’s Sun Pharmaceutical Industries Ltd is recalling 41,127 bottles of anti-depressants venlafaxine hydrochloride in the United States after the drug failed to dissolve properly, the U.S. Food and Drug Administration (FDA) said.
The voluntary recall by Sun Pharma’s unit Caraco Pharmaceutical Laboratories Ltd in June was classified by the FDA as Class II, meaning that use of or exposure to the drug may cause temporary or medically reversible adverse health consequences.
The FDA commonly conducts dissolution tests to help predict how a drug performs inside the body.
Sun Pharma manufactures this drug at its plant in the western Indian state of Gujarat.
The company’s recall of venlafaxine hydrochloride comes three months after Pfizer Inc. announced it was pulling 104,000 bottles of the same drug, which the U.S. company sells under the brand name Effexor XR, after a pharmacist reported that one of the bottles contained a heart drug.
Sun Pharma recalled 200 vials of the chemotherapy drug gemcitabine in the U.S. in April due to a lack of assurance of sterility.
In January, the company pulled 2,528 bottles of its generic version of the diabetes drug Glumetza.
For more information on this recall, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).