Wockhardt's voluntarily recalls captopril tablet from market

Wockhardt has initiated recall of 93,393 bottles of blood pressure drug captopril tablets in the US market due to failing to meet specifications. It is a Class II 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 recall was because of the tablets failed to meet tablet/capsule specifications and were out of specification for thickness, the US FDA said on its website.

Captopril is a ß blocker and is used to treat hypertension, heart failure and to improve survival after a heart attack. According to the US Food and Drug Administration (FDA) website, Mumbai-based drugmaker's US arm Wockhardt USA Inc is recalling 13 lots of prescription-only drug captopril tablets, USP 12.5 mg in 100 and 1,000 count bottles. The drug was manufactured in the company's facility in India; though no clear mention has been made about the facility.

Last month wockhardt voluntarily recalled about 12-15 drugs in the US which were manufactured at its two facilities in Chikalthana and Waluj in Aurangabad, prior to the import alert imposed on the facilities by the US FDA.