Drug firm Wockhardt is recalling 93,393 bottles of Captopril tablets, used for treatment of high blood pressure and kidney problems caused by diabetes, for failing to meet specifications for thickness.
Wockhardt USA Inc, American arm of the Mumbai-based firm Wockhardt Ltd, is undertaking a voluntary nationwide ongoing recall of 93,393 bottles of Captopril tablets, according to information available on the USFDA site.
The Class II recall has been initiated as the tablets failed to meet tablet/capsule specifications as they were “out of specification for thickness,” the United States food and Drug Administration (USFDA) said in its latest Enforcement Report. A Class II recall is made in a situation in which 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.
In April this year, Wockhardt had said it was recalling 13 drugs in the US, manufactured at its two units at Chikalthana and Waluj in Maharashtra, which were under import restrictions from the USFDA.
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