Dr. Reddy’s, which already has three plants targeted in a warning letter by the FDA, is now recalling products manufactured at another.
According to the most recent FDA Enforcement Report, the Indian maker of generic drugs is recalling 50,280 bottles of ondansetron tablets in the U.S. that were manufactured at a facility in Bachupally, India. The report says the tablets, used to prevent nausea and vomiting, failed impurities testing at the 12-month mark.
Dr. Reddy’s has had several recalls lately, including in February when it retrieved 25,000 bottles of a dialysis drug after getting a host of customer complaints of container leaks. The recalls return the spotlight to the company which last year received FDA warnings for active ingredient plants in Srikakulam and Miryalaguda, as well as its Oncology Formulation manufacturing facility at Duvvada.
The agency listed a host of issues at the plants but was particularly ticked off by the discovery that for years the company had what the FDA termed an "uncontrolled Custom QC laboratory" at its plant in Srikakulam. The plant had often shipped products to the U.S. that had repeatedly failed tests for impurities.
Despite the problems, the company has been able to grow its business in the U.S. On Thursday, it reported that for the year ending March 31, sales in North America were up 19% to Rs 75.4 billion ($1.1 billion), driven by its sterile injectables business.
- access the FDA Enforcement Report here
Related Articles:
Dr. Reddy's blasted in warning letter for hiding existence of testing lab from FDA
Dr. Reddy's recalling injected drug manufactured by Gland Pharma
Dr. Reddy's grows U.S. sales even in face of FDA action