India's Wockhardt may have two of its plants banned by the FDA from shipping to the U.S. but it still has product on the market and it says some of it needs to be recalled. The drugmaker is retrieving nearly 95,000 bottles of blood pressure tablets because they are out of spec for thickness.
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| Wockhardt Chairman Habil Khorakiwala |
According to the FDA's most recent Enforcement Report, Wockhardt began voluntarily recalling 13 lots, 93,393 bottles, of captopril in March after discovering some tablets failed specifications. It was not clear from the recall at which plant the pills were manufactured.
In 2013, the FDA banned Wockhardt's plants in Chikalthana and Waluj for a long list of issues that it outlined in a warning letter. That included quality-assurance personnel hiding records of batch failures and attempting to destroy some test samples. Inspectors also uncovered "unofficial" records on 75 batches that had a 14% failure rate and problems from black particles to fibers and glass particles in them, while "official records" indicated that the batches all met specifications. There were also sanitation issues.
Wockhardt's problems have not been contained solely to the U.S. The U.K. and Europe also blocked sales from some of Wockhardt's plants in 2013. And while the U.S. never asked Wockhardt to recall products, the drugmaker was ordered to recall 16 meds in the U.K.
The status of improvements that Wockhardt is making is unknown for the Chikalthana plant, but during a reinspection at Waluj this year the FDA found progress there lacking. While the specifics of that visit have not been made public, Wockhardt CEO Habil Khorakiwala has insisted they were not serious and that the company is working on them.
- here's the recall notice