Cipla, Wockhardt among FDA recalls as India manufacturing woes continue

Cipla and Wockhardt each announced drug recalls from the U.S. market, the former because of failure to meet specifications, the latter because of U.S. FDA concerns about two of its India plants. A Japan devicemaker also announced a U.S. recall.

Cipla said its recall involved 140,625 vials of an asthma inhalant, levalbuterol, produced in its Pithampur plant for Dr. Reddy's Laboratories ($RDY). The recall amounted only to a Class III because the problem was not likely to cause serious problems in patients.

Cipla said the tested samples from a batch of the drug indicated it had "failed impurities and degradation specifications."

Wockhardt said it recalled a dozen of its drugs remaining on the U.S. market because they were produced at either of two India plants now under an import ban imposed by the U.S. FDA. The agency already had questioned Wockhardt's continued marketing of drugs produced in those problem plants.

The company's founder, Habil Khorakiwala, said it looked at its situation and "we thought it would be more prudent to just take a voluntary recall decision across all the products which were there before the alert."

Fujifilm Medical Systems U.S.A. issued a Class II recall of its Synapse cardiovascular diagnostic, saying it contained two instances of software information in conflict with a clinical report.

- here's the FDA notice
- and stories from NDTV and the Financial Express