Two major Indian pharmaceutical firms, Dr Reddy’s Laboratories and Zydus Lifesciences, have recalled specific medicines from the US market due to manufacturing issues. The US Food and Drug Administration (USFDA) reported the recalls in its latest enforcement notice.
Dr Reddy’s American subsidiary initiated a recall of 571 vials of Succinylcholine Chloride Injection, used to relax muscles. The decision came after “out-of-specification” results appeared in six-month stability tests. The product is being withdrawn across the United States as a Class II recall, which suggests temporary or reversible health risks.
Zydus Pharmaceuticals (USA) Inc, a subsidiary of Zydus Lifesciences, recalled over 1,500 boxes of Entecavir tablets used for chronic hepatitis B. The recall covers 912 bottles of 0.5 mg and 600 bottles of 1 mg tablets. The USFDA cited impurity and degradation issues as the reason for the action.
India hosts the largest number of USFDA-approved drug plants outside the US. These recalls show the strict quality standards followed by Indian companies and American regulators. Similar recalls by Sun Pharma and Lupin have occurred in the past to ensure patient safety.
