Wockhardt’s Woes Continue With Blood Pressure Tablet Recall
Beleaguered Indian generics maker Wockhardt is recalling 93,393 bottles of its blood pressure medicine Captopril in the U.S., after discovering the tablets failed to meet specification for thickness.
Wockhardt’s U.S. arm initiated the nationwide voluntary Class II recall of 13 lots of the drug on March 12. The recall is included in a May 13 FDA Enforcement Report.
This is Wockhardt’s second recall in as many months. On April 28, the company began recalling from the U.S. market all remaining batches of 12 to 15 products made at its Waluj and Chikalthana, India, plants, due to quality concerns.
It’s not clear what plant manufactured the Captopril tablets. The Waluj and Chikalthana facilities have been under an FDA import alert banning distribution of their products in the U.S. since November 2013.
The latest recalls follow two major recalls last year related to issues affecting how drugs dissolved. In April 2014, Wockhardt recalled 109,744 bottles of its hypertension drug metoprolol, and three months later recalled more than 11,600 bottles of generic Toprol-XL.
Last April, India suspended sales of Wockhardt’s fixed-dose combination dicyclomine hydrochloride 10 mg, tramadol hydrochloride 50 mg and acetaminophen 325 mg following the FDA import alert and the July recall. Regulators in the UK also ordered the firm to stop making products for the European market.
Wockhardt did not return a request for comment by press time.
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