Indian drug makers Sun Pharmaceutical Industries and Lupin are recalling 41,737 bottles of three drugs used for illnesses such as high blood pressure, depression and anxiety. The drugs are made for the U.S. market.
Sun Pharmaceutical Industries Inc. is recalling 12,109 bottles of carvedilol tablets used for treatment of high blood pressure, according to the latest enforcement report from of the U.S. Food and Drug Administration (FDA), Moneycontrol.com reports.
The recall covers 3.125 mg., 6.25 mg., 12.5 mg. and 25 mg. tablets. The recall is due to “failed impurities/degradation specifications.” The tablets were manufactured in Hungary at Aldaloida Chemical Company Zrt, a subsidiary of Sun Pharma.
Lupin is recalling 3,192 bottles of the SSRI depression medication escitalopram and 26,436 bottles of the blood-pressure medication lisinopril.
The 20 mg. escitalopram tablets were recalled because of “Labeling: incorrect or missing lot and/or expiration date,” according to the FDA the report. The product was made for Lupin Pharmaceuticals Baltimore by Lupin at its Goa facility. The lisinopril 30 and 40 mg. tablets were recalled because the active ingredients in the finished products did not meet specification. The lisinopril tables were made at Lupin’s Pithampur facility.
All three recalls were designated Class III recalls, the FDA’s lowest-risk recall category. According to the FDA, in a Class III recall, “use of, or exposure to, a violative product is not likely to cause adverse health consequences.”