FDA Recalls CKD Drug Cinacalcet

The US Food and Drug Administration (FDA) issued a recall of a drug used to treat chronic kidney disease (CKD) and other conditions.

Cinacalcet that is manufactured in India and sold by Dr. Reddy’s Laboratories of Princeton, New Jersey, has been pulled because of potential impurities. The recalled batch of cinacalcet may contain harmful levels of nitrosamines, which are considered potentially carcinogenic.

Dr. Reddy’s Cinacalcet Tablets are available in 30 mg, 60 mg, and 90 mg tablets. The recall involves 285,126 thirty-count bottles of 30 mg tablets with code NDC 43598-367-30. A full list of the affected lots with expiration dates can be found on the FDA website.

The FDA classified the risk level of the recall as Class II, meaning there is “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

Cinacalcet is a calcimimetic that can lower parathyroid hormone levels, thereby helping to control calcium. This has potential bone and cardiovascular benefits for patients with CKD.