Pharma company Wockhardt's US subsidiary has initiated recall of 93,393 bottles of blood pressure drug captopril tablets in the US market due to failed specifications.
Pharma company Wockhardt's US subsidiary has initiated recall of 93,393 bottles of blood pressure drug captopril tablets in the US market due to failed specifications.
The drug 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.
The class II recall, which was initiated on March 12, 2015, was because the tablets failed to meet tablet/capsule specifications and were out of specification for thickness, the US FDA said on its website.
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.
Last month Wockhardt chairman Habil Khorakiwala said it was voluntarily recalling 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. However, he had said that there were a few drugs that were allowed to be manufactured by the US drug regulator post import alert, and they are not on the recall lists of drugs.
Whether this particular recall is a part of the list of drugs which the company has decided to voluntarily to withdraw from the US market is not known. A query sent to the company did not elicit any response.
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