A unit of Zydus Lifesciences is recalling over 7,000 bottles of Oxybutynin Chloride tablets in the U.S. due to manufacturing issues, according to the U.S. Food and Drug Administration (USFDA).
As per its latest Enforcement Report, the U.S. 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 U.S.
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 U.S. by Zydus Pharmaceuticals (USA) Inc, the U.S. health regulator stated.
The drug firm initiated the Class II recall on Sept. 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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