Dr. Reddy’s has had its own regulatory issues recently, but its latest recall of hundreds of thousands of cartons of a popular acne treatment is for product manufactured by compatriot Cipla.
According to FDA enforcement reports here, here and here, Dr. Reddy’s is recalling 185 lots, consisting of 765,058 cartons of its Zenatane brand isotretinoin capsules, in three dose sizes. The report says the products were produced by Cipla at a plant in Pune, India. The voluntary Class II recall was initiated in late May after the products were deemed to have failed dissolution testing.
While the product was not manufactured by Dr. Reddy’s, the recall comes as the drugmaker continues to deal with a host of regulatory issues at several of its plants. The company recently reported that an inspection of its formulation plant in Bachupally in Hyderabad resulted in a Form 483 with 11 observations.
Shortly before that, India’s second-largest drugmaker reported that the FDA issued a Form 483 with two observations during a return visit to its API plant in Srikakulam. The Srikakulam plant figured prominently in the three-plant warning letter the FDA issued to Dr. Reddy’s in 2015. In February, the FDA returned to a Dr. Reddy’s API plant in Miryalaguda and issued a Form 483 with three observations. That plant was also included in the 2015 warning letter.