The U.S. unit of Indian drugmaker Dr. Reddy’s Laboratories is recalling 331,590 bottles of cinacalcet tablets used to treat hyperparathyroidism due to the presence of a known carcinogen.
The company issued three separate recalls for drugs that were distributed nationwide in the U.S. The recalls started on October 9 and were recently posted on the FDA's website.
A specific production site or sites for the drugs wasn’t disclosed. The actions have been listed as Class II recalls for drugs that may cause temporary or reversible adverse health consequences, but where the risk of serious consequences is low.
The company found traces of a nitrosamine-related impurity that were above a proposed interim limit set by the regulatory agency, according to the notices.
Dr. Reddy’s last issued a voluntary recall back in April when it pulled six lots of sapropterin dihydrochloride powder used to treat phenylketonuria due to potential potency issues following internal testing and customer complaints of discoloration in some packets.
Elsewhere, the company was severely chastised when it was cut off from China’s bulk-buy drug procurement program in September following a plant in inspection by the country’s National Medical Products Administration. The agency found “serious defects” in manufacturing operations and suspended use of Dr. Reddy’s atomoxetine hydrochloride capsules for attention-deficit/hyperactivity disorder.