Indian drug companies, Dr. Reddy’s Laboratories and Zydus Lifesciences, have both been asked by the US health regulator, USFDA, to recall certain drugs manufactured in the US for not meeting safety standards.
In its latest Enforcement Report, US Food and Drug Administration (USFDA) stated that an American subsidiary of the Hyderabad-based drug major, Dr. Reddy’s Laboratories Inc is recalling 571 vials of an injection used to relax muscles.
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.
The company initiated the nationwide (US) Class II recall on September 26 this year.
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The health regulator further 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.
With a unit in Pennington, New Jersey, 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.
As per 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.
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