Three More Companies Issue Recalls Due to NDMA Impurities

October 24, 2019
Pharmaceutical Technology Editors

Dr. Reddy’s, Sanofi, and Perrigo Company issued voluntary recalls of ranitidine in October 2019 because of N-Nitrosodimethylamine contamination.

Sanofi, Dr. Reddy’s Laboratories, and Perrigo Company have initiated voluntary recalls of ranitidine products, such as Zantac, because of possible N-Nitrosodimethylamine (NDMA) contamination. NDMA contamination has been an ongoing situation that regulators in both the United States and Europe have been addressing since 2018. In September 2019, FDA alerted patients about NDMA being discovered in samples of ranitidine. Ranitidine, a heartburn treatment, is available both over the counter (OTC) and in prescription form. 

Sanofi initiated a voluntary recall of all Zantac OTC in the US on Friday, October 18, including Zantac 150, Zantac 150 Cool Mint, and Zantac 75. “Evaluations are ongoing on both drug substance (active ingredient) and finished drug product. Due to inconsistencies in preliminary test results of the active ingredient used in the US products, Sanofi has made the decision to conduct the voluntary recall as the investigation continues,” Sanofi stated in a press release.

On October 23, Dr. Reddy’s Laboratories Ltd. confirmed it initiated a voluntary recall on October 1, 2019 of its ranitidine medications sold in the US because of confirmed contamination with NDMA above established FDA levels. The company announced it had not received any reports of adverse events related to the recall. 

Perrigo halted production of shipments of its products on October 8 based on preliminary results. The company began testing its ranitidine API and products after regulators announced the potential problem of NDMA contamination.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

FDA provided an update on the NDMA contamination problem on Oct. 23, 2019. 

Source: FDA