Drug major Dr. Reddy's Laboratories Ltd. is recalling 33,958 bottles of Divalproex Sodium Extended-Release tablets, used to treat seizure disorders, from the American market, as per a report by the U.S. health regulator.
Besides, InvaGen Pharmaceuticals Inc, a subsidiary of Mumbai-based drug maker Cipla Ltd., is recalling over 7.8 lakh vials of Testosterone Cypionate injection, used to treat low testosterone levels in men.
Dr. Reddy's Laboratories Inc, a subsidiary of the Hyderabad-based Dr. Reddy's Laboratories, is voluntarily recalling the affected lot of bottles on account of certain deviations from the Current Good Manufacturing Practice regulations.
As per the latest enforcement report by the U.S. Food and Drug Administration, the firm is recalling the product as it has been exposed to above 50 percent relative humidity levels during packaging operations.
The product was supplied to major distributors and retailers who may have further distributed the product throughout the U.S., the report added.
Meanwhile, InvaGen Pharmaceuticals Inc is recalling its product in various strengths due to the “presence of particulate matter”, the report said.
The vials were manufactured by Cipla at its Verna facility in Goa for Cipla USA Inc.
The U.S. FDA has classified both the recalls as a Class-II recall, which is initiated in a “situation in which 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.”
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