Daijiworld Media Network - Hyderabad

Hyderabad, Oct 12: Indian pharmaceutical giants Dr Reddy’s Laboratories and Zydus Lifesciences have recalled batches of their products from the US market due to manufacturing concerns, the US Food and Drug Administration (USFDA) said in its latest Enforcement Report.

Princeton-based Dr Reddy’s Laboratories Inc., an American subsidiary of the Hyderabad-headquartered company, has recalled 571 vials of Succinylcholine Chloride Injection, a muscle relaxant, following “Out-of-Specification results” detected during six-month stability testing. The nationwide Class II recall began on September 26.

Similarly, Zydus Pharmaceuticals (USA) Inc., a New Jersey-based arm of Zydus Lifesciences, initiated a Class II recall of over 1,500 bottles of Entecavir tablets—an antiviral drug used to treat chronic hepatitis B. The recall, launched on September 24, involves 912 bottles of the 0.5 mg strength and 600 bottles of the 1 mg strength due to “failed impurity/degradation specifications.”

According to the USFDA, a Class II recall is issued when the use of or exposure to a product may cause temporary or medically reversible health effects, with minimal risk of serious health consequences.

India continues to lead globally in the number of USFDA-approved pharmaceutical manufacturing facilities outside the United States.