Zantac Lawsuits Mount, as Ranitidine Recalls Continue

Published on December 18, 2019 by Laurie Villanueva

Zantac lawsuits are mounting in courts throughout the United States, as drug manufacturers continue to announce recalls for ranitidine products that may be contaminated with a cancer-causing substance.

Zantac Breast Cancer Lawsuit Filed in Florida

One of the most recent Zantac lawsuits was filed on behalf of a 44-year-old Florida woman diagnosed with breast cancer last August. Prior to her diagnosis, Jill Goldstein had used over-the-counter Zantac to treat heartburn symptoms for nearly two decades.

According to a complaint now pending in U.S. District Court, Southern District of Florida, a 2008 study conducted by a cancer research institute in California suggested that those who regularly take ranitidine-containing heartburn drugs face a 240% greater risk of developing ductal carcinoma than those who don’t use the medications.

“If only the makers of Zantac had put aside their greed and heeded the 2008 peer-reviewed study by the Fred Hutchinson Cancer Research Center, Jill Goldstein would not be going through the hell she is subjected to now,” the lawsuit states.

Goldstein is just one of dozens of plaintiffs nationwide who claim Zantac caused their cancer. However, according to The Palm Beach Post, her lawsuit is the first to point out that researchers had actually identified a cancer risk more than a decade ago.

Zantac Contaminated with Known Carcinogen

Plaintiffs began filing Zantac lawsuits shortly after the U.S. Food & Drug Administration (FDA) notified the public that samples of the drug had test positive for N-nitrosodimethylamine (NDMA) – a probable human carcinogen. The FDA learned of the issue from Valisure, an online pharmacy that apparently found the chemical in every sample of Zantac and ranitidine it tested, and often at level’s that far exceeded the agency’s recommended daily limits.

Valisure maintains that NDMA in Zantac resulted from the instability of the ranitidine molecule, which may degrade when subjected to conditions similar to digestion. While the FDA has yet to conclude that ranitidine actually produces NDMA in the stomach, the agency has ordered new testing to determine if the carcinogen is formed when ranitidine is exposed to chemicals that naturally occur during digestion.

Most recently, the FDA asked drug makers test all Zantac and ranitidine lots before making them available to consumers.

“If testing shows NDMA above the acceptable daily intake limit (96 nanograms per day or 0.32 parts per million for ranitidine), the manufacturer must inform the agency and should not release the lot for consumer use,” the FDA said.

The FDA has not ordered any Zantac recalls; however, consumers who use over-the-counter ranitidine products have been advised to consider switching to alternative heartburn drugs. Those taking prescription Zantac should not stop using the medication without talking with their doctor, as doing so could worsen the condition being treated.

Glenmark Pharmaceuticals Ranitidine Recall

Numerous drug makers have opted to voluntarily recall their Zantac and ranitidine products. Just yesterday, Glenmark Pharmaceuticals recalled its prescription ranitidine tablets because they might contain NDMA above acceptable levels.

This latest ranitidine recall includes:

  • Ranitidine Tablets, USP 150mg. Expiration dates: 12/2019 – 5/2022, with one of the following NDC numbers printed on the product label: 684620-248-60; 684620-248-01 and 684620-248-05.
  • Ranitidine Tablets, USP 300mg. Expiration dates: 12/2019 – 6/2022, with the following NDC numbers: 684620-249-30; 684620-249-01; and 684620-249-20.

Customers who purchased Glenmark’s recalled ranitidine tablets can call Qualanex at 1-888-504-2012, Monday – Friday, 9:00 am – 5:00 pm, EST to arrange for product return.

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