Dr Reddy’s, Zydus recall products in US over quality issues
Dr Reddy's subsidiary recalls muscle relaxant injection for stability failure; Zydus recalls over 1,500 boxes of antiviral tablets over impurity
Drug majors Dr Reddy’s Laboratories and Zydus Lifesciences are reportedly in the process of recalling products in the US for manufacturing issues.
In its latest Enforcement Report, the US Food and Drug Administration (USFDA) has stated that an American subsidiary of the Hyderabad-based drug major is recalling 571 vials of an injection used to relax muscles.
The Princeton-based Dr Reddy’s Laboratories, Inc. is recalling the affected lot of Succinylcholine Chloride Injection due to “Out-of-Specification result during the six-month stability testing,” the USFDA stated.
Also read: Glenmark, Sun Pharma, Zydus recall products in US
The company initiated the nationwide (US) Class II recall on September 26 this year.
Class-II recall
The USFDA stated that the US-based arm of Zydus Lifesciences is recalling over 1,500 boxes of an antiviral medication used primarily to treat chronic hepatitis B virus.
The Pennington, New Jersey-based Zydus Pharmaceuticals (USA) Inc is recalling 912 and 600 bottles of Entecavir tablets in strengths of 0.5 mg and 1 mg respectively due to “failed impurity/degradation specifications”, it added.
The drug firm initiated the Class II nationwide recall on September 24.
Also read: Dr Reddy's recalls 3.3 lakh bottles of generic medicine in US
According to the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.
India has the highest number of USFDA-compliant pharmaceutical plants outside of the US.
(With agency inputs)