According to the US Food and Drug Administration (FDA), 166 bottles of captopril tablets of 50 mg strength has been recalled along with 50 bottles of clarithromycin tablets of 500 mg strength.
The US drug regulator in its recent notification said the blood pressure drug Captopril and antibiotic Clarithromycin tablets manufactured by Wockhardt are being recalled in the US for deviation in the good manufacturing practices.
According to the US Food and Drug Administration (FDA), 166 bottles of captopril tablets of 50 mg strength has been recalled along with 50 bottles of clarithromycin tablets of 500 mg strength.
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 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.
The recall of both these drugs were initiated on May 22, the FDA notification said.
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.
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.
In April, Wockhardt chairman Habil Khorakiwala said the company was voluntarily withdrawing about 12-15 drugs from the US which were manufactured at its two facilities in Aurangabad, Chikalthana and Waluj, prior to the import alert imposed on the facilities by the US FDA. The chairman indicated that $1-1.5 million would be the business impact from this decision.
Khorakiwala, however, also 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.
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