Wockhardt again recalls captopril tablets from market along with clarithromycin tablets
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.