Cipla pulls levalbuterol on FDA warning; Wockhardt removes other drugs on concerns

Cipla announced a drug recall of its asthma inhalant levalbuterol from the U.S. market following an FDA warning, and Wockhardt withdrew about a dozen drugs on manufacturing concerns at two of its plants in India.

The Cipla recall was for 140,625 vials of levalbuterol manufactured in its Pithampur facility for Dr. Reddy's Laboratories ($RDY) because samples showed the product "failed impurities and degradation specifications." The recall was designated by the U.S. regulatory agency as Class III, which means it's not likely to cause serious problems in patients.

Wockhardt Chairman Habil Khorakiwala

The Wockhardt voluntary recall was for a dozen drugs that circulated in the U.S. that were produced at one of two plants in India that are under a ban imposed by the FDA.

"We thought it would be more prudent to just take a voluntary recall decision across all the products which were there before the alert," company founder Habil Khorakiwala said.

The FDA banned the Wockhardt plants in Waluj and Chikalthana in 2013 after it was discovered that employees had manipulated data to indicate that batches that failed testing met specifications. The company then sold those drugs in the U.S.

- check out the Cipla warning
- see the Financial Express story on Wockhardt

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