Drug major Dr Reddy’s Laboratories 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 US health regulator.
Besides, InvaGen Pharmaceuticals Inc, a subsidiary of Mumbai-based drug maker Cipla, 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 (CGMP) regulations.
As per the latest enforcement report by the US Food and Drug Administration (USFDA), the firm is recalling the product as it has been exposed to above 50% relative humidity levels during packaging operations.
The product was supplied to major distributors and retailers who may have further distributed the product throughout the US, 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 USFDA 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.”