IGMPI India

Wochardt has recently recalled 166 bottles of captopril tablets of 50 mg strength along with 50 bottles of clarithromycin tablets of 500 mg strength. The pharma company in March this year also initiated recall of 93,393 bottles of the captopril tablets of strength 12.5 mg in 100 and 1000 count bottles. According to the USFDA the company recalled blood pressure drug Captopril and antibiotic Clarithromycin tablets in the US due to deviation in the good manufacturing practices. Blenheim Pharmacal Inc, the packaging company, is the recalling firm while the drugs were distributed by Wockhardt USA LLC, the US subsidiary of the Mumbai-based pharma company.

The recalls of both of the drug were initiated on May 22, the FDA notification said.

Recall was classified as a Class 2 recall. A class II recall is made when there is 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.

The reason for the Class II recall is given as current good manufacturing practice (cGMP) deviations, products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following an FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure.