Dr Reddy’s and Zydus Lifesciences Recall Medicines in US Due to Quality Concerns
Dr Reddy’s Zydus Lifesciences medicine recall US quality issues has raised concerns as both companies recalled medicines in the US, highlighting the need for strict compliance and safety standards.
New Delhi : Two major Indian pharmaceutical companies, Dr Reddy’s Laboratories and Zydus Lifesciences, are recalling certain medicines from the US market due to manufacturing issues, according to the US health regulator. This situation of Dr Reddy’s Zydus Lifesciences medicine recall US quality issues highlights ongoing regulatory challenges.
The latest enforcement report by the US Food and Drug Administration (USFDA) states that an American subsidiary of Hyderabad-based Dr Reddy’s is recalling 571 vials of Succinylcholine Chloride Injection, a medicine used to relax muscles, further emphasizing the recall concerns.
The USFDA initiated the recall on September 26 after it detected an “out-of-specification result during six-month stability testing.”
Dr Reddy’s affected batch is being withdrawn nationwide in the United States as a Class II recall, which indicates that exposure may cause temporary or reversible health problems, but serious health issues are unlikely.
Similarly, Zydus Lifesciences’ US arm, Zydus Pharmaceuticals (USA) Inc, is recalling over 1,500 boxes of Entecavir tablets, an antiviral medicine used mainly to treat chronic hepatitis B.
The company began the recall on September 24, covering 912 bottles of 0.5 mg tablets and 600 bottles of 1 mg tablets. The USFDA cited failed impurity and degradation specifications as the reason for the recall.
India hosts the largest number of USFDA-compliant pharmaceutical plants outside the United States, and such recalls underline the strict regulatory oversight maintained by US authorities.
This is not the first time Indian drug makers have recalled medicines from the US market.
Earlier, companies like Sun Pharma, Lupin, and Dr Reddy’s initiated similar recalls over product mix-ups and quality issues, ensuring they maintain patient safety as a priority.
In July this year, Sun Pharmaceutical Industries, headquartered in Mumbai, recalled 5,448 bottles of a generic ADHD drug. The medicine, Lisdexamfetamine Dimesylate capsules, failed to meet required dissolution standards during testing.
–IANS
