The manufacturing misfortunes keep piling up for Dr. Reddy’s, even as the Indian drugmaker is trying to sort through issues that led to a warning letter. The most recent recall involves an over-the-counter antacid produced for the pharmacy chain CVS.
According to the FDA’s most recent Enforcement Report, the drugmaker began a voluntary recall in April of three lots--totalling 84,240 bottles--of famotidine tablets distributed as CVS pharmacy Original Strength Acid Controller tablets. The report doesn’t say where the tablets were manufactured.
The reason for this recall? A sample was determined to be out of specification for an individual related substance during stability testing at the 18th month interval.
A failed impurities test was the same reason Dr. Reddy’s recently recalled 50,280 bottles of the anti-nausea med ondansetron in the U.S. that were manufactured at a facility in Bachupally, India.
Dr. Reddy’s has had a string of 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.
- access the recall here
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