Aurobindo Announces Generic Zantac Recall

Published on November 11, 2019 by Sandy Liebhard

Aurobindo Pharma USA has become the latest drug maker to announce a Zantac-related recall amid concerns that ranitidine-containing heartburn drugs might be contaminated with a cancer-causing chemical.

7^th Zantac-Related Recall Since September

This latest recall – the seventh since September 13^th – involves 37 lots of Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL. A complete list of the medications, National Drug Codes (NDC), batch numbers, and expiration dates can be found here.

Aurobindo is conducting the recall at the consumer level. The products were distributed nationwide to Aurobindo Pharma USA, Inc. and AuroHealth wholesale and distributor customers from September 28, 2018 through September 19, 2019.

Patients who have been prescribed one of the ranitidine products included in the recall should continue taking the medication, as stopping could cause their condition to worsen. However, they are also advised to contact their doctor or pharmacist to discuss alternative treatment options.

According to the recall notice, the affected drugs may contain N-nitrosodimethylamine (NDMA), a probable human carcinogen.  So far, Aurobindo Pharma USA, has not received any reports of adverse events related to this recall.

Zantac and NDMA: The Controversy

On September 13^th, the U.S. Food & Drug Administration (FDA) warned that some samples of Zantac and ranitidine had tested positive for the presence of NDMA. The agency was informed of the contamination by Valisure, an online pharmacy that said it found NDMA in every medication sample it tested, and often at levels far above the FDA’s recommended daily limits.

Valisure contends that the NDMA resulted from the instability of the ranitidine molecule, which the company claims degrades under conditions similar to human digestion.

Last week, the FDA said its preliminary tests suggests that Zantac does not produce NDMA in the stomach. However, the agency is planning human tests in the near future to fully understand whether the chemical forms after ingestion.

The FDA’s own published results show that some over-the-counter Zantac and ranitidine products had as much as nine-times the agency’s acceptable limit of NDMA.

Zantac Recalls and Lawsuits

So far, the FDA has not ordered any drug makers to recall their Zantac or ranitidine medications. However, several have opted to conduct voluntary recalls, including Sanofi-Aventis, Sandoz, GlaxoSmithKline, and Dr. Reddy’s Laboratories. A number of retailers, including CVS, Walmart, and Rite-Aid, have also decided to remove the drugs from store shelves.

Since the issue surfaced, a growing number of plaintiffs have filed Zantac lawsuits, including class action that seek economic damages and medical monitoring for purchasers of contaminated drugs, as well as personal injury claims for cancer allegedly caused by NDMA in Zantac.

Earlier this month, several plaintiffs asked that all federally-filed cases of this nature be consolidated in a single federal court for the purpose of coordinated discovery and other pretrial proceedings.