American Health Packaging announced yet another recall of 150 milligram Zantac pills because the heartburn drug has high amounts of the cancer-causing impurity NDMA.
Several recalls were made earlier by Appco Pharma LLC, Aurobindo Pharma USA, Sanofi, GlaxoSmithKline, Glenmark Pharmaceutical Inc., Novartis, Dr. Reddy’s Laboratories, Perrigo, Novitium Pharma, and Lannett Company.
Walmart, Walgreens, CVS, and Rite Aid also pulled prescription and over-the-counter varieties of the drug from their shelves.
Zantac (Ranitidine) provides heartburn relief for acid in the stomach and has been sold in the US for more than 30 years. The recalled batches of the drug contained high levels of N-Nitrosodimethylamine (NDMA).
NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. According to the Environmental Protection Agency, animals exposed to the chemical have developed tumors in the liver, blood vessels, kidneys, and respiratory tract.
Plaintiffs have filed 140 federal lawsuits against Zantac drug makers, as of February 19, 2020. They are consolidated in MDL 2924 before US District Judge Robin L. Rosenberg in West Palm Beach, Florida, IN RE: Zantac (Ranitidine) Products Liability Litigation.
The defendants include:
- Boehringer Ingelheim Pharmaceuticals, Inc.
- GlaxoSmithKline LLC
- Pfizer Inc.
- Sanofi-Aventis U.S. LLC
- Sanofi US Services Inc.
- Chattem, Inc.
Many lawsuits to come
The Plaintiffs have cancer of the bladder, kidney, colon, and stomach, and charge that the manufacturers, sellers, and distributors of Zantac knew that it contained NDMA and that the defendants concealed the NDMA-associated dangers posed to consumers.
Plaintiffs argue that NDMA is inherent to the drug’s molecular structure. Also, in a January 2, 2020 letter to the FDA, the Emery Pharma lab said that prolonged heat exposure can increase NDMA to unsafe levels in ranitidine. “This was concerning since significantly elevated temperatures can occur within closed vehicles during transportation and during storage of the drug,” the company.
Plaintiff attorney Robert Hilliard of Hilliard Martinez Gonzales said that his firm has already been hired by 15,000 consumers.
“Zantac will ultimately be one of the biggest consumer frauds ever perpetrated by Big Pharma,” Hilliard said. He believes consumer claims are backed by strong scientific evidence.
Concerns over Zantac began in 2019 when Valisure, an online pharmacy, discovered NDMA in batches of ranitidine during routine independent testing.
Valisure reported in a Sept. 9, 2019, FDA citizens petition letter that it detected extremely high levels of the chemical in every lot it tested across multiple manufacturers. The company said one tablet of Zantac may contain amounts of NDMA several thousand times higher than acceptable FDA limits.
The FDA announced on Sept. 13, 2019, that trace amounts of NDMA were found in Zantac.
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