Apotex recalls cevimeline hydrochloride drugs made in India as FDA notes stability issues

Within weeks of getting a conditional nod to resume shipments from two of the company's manufacturing units in India, Canada's largest generics maker has recalled 117,644 bottles of cevimeline hydrochloride capsules in the U.S. that were made by the company's Indian arm, Apotex Research, the Business Standard newspaper reports.

The newspaper said the U.S. FDA cited "failed stability specifications" on its website as the reason for the recall, which was initiated by the company on Aug. 17, for the treatment of dry mouth in patients with Sjogren's syndrome.

In September last year, drugs and APIs from two Apotex plants in the southern Indian city of Bangalore were placed under an import ban in Canada and the United States after inspectors from the U.S. FDA found evidence that drug sample testing was flawed. Products from the plant remain banned in the U.S.

Late last year, FDA inspectors found that employees had deleted data of failed test results and then reported that the batches had passed, a practice Apotex had received warnings about during inspections dating back 8 years.

This year, Apotex recalled more than 35,000 bottles of generic Zyprexa, an antipsychotic, that were manufactured at a plant in Toronto that was recently nicked by the FDA for a number of issues and recalled 91,962 bottles of Losartan potassium tablets made by Apotex Research in India.

The company's Indian arm did not respond to a request for comment, Business Standard said.

- here's the story from Business Standard