Dr. Reddy's, fighting to recover from FDA warning letter, recalls 500K heartburn tablets

Still struggling to turn its manufacturing around, Dr. Reddy's is recalling 569,000 store-brand famotidine tablets in the U.S., thanks to failed tests for impurities and degradation. It's the India-based company's second recall of the same medication since last July.

The meds were sold at CVS pharmacies as CVS Pharmacy Acid Controller and at Walmart under the Equate label, according to the FDA's latest Enforcement Report. It's a Class III recall, meaning the suspect drugs aren't likely to cause injury to humans.

Dr. Reddys pulled more than 84,000 famotidine tablets, also produced for CVS, last July. In both cases, the company found an out-of-specification result during routine stability testing. The new recall is nationwide.

The latest recall comes as the generics maker continues to suffer FDA citations at multiple manufacturing plants, including some included in a 2015 warning letter. Its ongoing manufacturing problems triggered a decline in U.S. sales, making a dent in its fiscal 2017 results announced in May.

That same month, Dr. Reddy's reported that an inspection of its Bachupally formulation plant in Hyderabad resulted in an FDA Form 483 with 11 observations.

That notice came as Harvard Drug Group recalled about 9,200 cartons of the antifungal drug fluconazole manufactured at the Bachupally plant. And it followed two other Form 483s, one in April and another in February, citing problems at active pharmaceutical ingredient (API) plants in Srikakulam and Miryalaguda that had featured in that 2015 warning letter.

The company's manufacturing issues also prompted a fraud lawsuit from South Korea's Mezzion. The FDA had rejected Mezzion's drug candidate udenafil because of manufacturing problems. Mezzion alleged that Dr. Reddy's repeatedly said it was compliant with FDA regulations when it was not and that Dr. Reddy's “was the sole reason given by the FDA” for denying udenafil's approval.

Oct 21, 2017


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