A unit of Zydus Lifesciences is recalling over 7,000 bottles of Oxybutynin Chloride tablets in the US due to manufacturing issues, according to the US Food and Drug Administration (USFDA).
As per its latest Enforcement Report, the US health regulator said the drugmaker is recalling 7,248 bottles of Oxybutynin Chloride extended-release tablets, used to treat overactive bladder and urinary conditions, in the US.
New Jersey-based Zydus Pharmaceuticals (USA) Inc. is recalling the affected lot due to “Failed Dissolution Specifications”, the USFDA stated.
The lot was produced at Ahmedabad and distributed in the US by Zydus Pharmaceuticals (USA) Inc, the US health regulator stated.
The drug firm initiated the Class II recall on September 21 this year.
As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
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First Published: Oct 13 2023 | 5:03 PM IST