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For the first time since it was discovered that the active ingredient in Zantac may convert to a cancer-causing chemical, federal regulators have announced a recall that does not involve ranitidine tablets, indicating that evidence of N-Nitrosodimethylamine (NDMA) has been found in a generic oral solution version of the heartburn drug.
Lannett Company announced the generic Zantac oral solution recall on October 25, after levels of NDMA were detected that are above the permissible daily limit. The recall affects about 100 lots, which were distributed nationwide.
Over the past few weeks, a steady stream of Zantac recalls have been issued by various manufacturers of prescription, over-the-counter and generic versions of the medication, which contains the active pharmaceutical ingredient ranitidine, due to a risk the pills may expose users to a known human carcinogen, NDMA. However, this appears to be the first recall of a product not sold in tablet form.
The FDA first warned about the Zantac problems on September 13, indicating several different versions of the heartburn drug have been found to contain the impurity, which could cause cancer. As a result, major retailers have removed Zantac from store shelves, and nearly every version of the medication has now been recalled.
“Lannett was notified by FDA of the potential presence of NDMA on September 17, 2019 and immediately commenced testing of the Active Pharmaceutical Ingredient (API) and drug product,” the manufacturer said in the recall announcement. “The analysis confirmed the presence of NDMA.”
The recall affects all lots within the expiration date of Ranitidine Syrup (Ranitidine Oral Solution, USP) 15mg/mL. It is packaged in 16 fluid ounce bottles with an NDC code of 54838-550-80.
The recalled medications were distributed nationwide by Lannett Company, Inc.
Zantac Cancer Concerns
Zantac (ranitidine) has been on the market for decades, and is regularly used by millions of Americans for treatment of heart burn and acid reflux. However, increasing evidence now suggests the active ingredient ranitidine is inherently unstable, and may convert to NDMA when stored at high temperatures, such as in a car, or inside the human stomach.
The problem with Zantac was first reported in the U.S. by the online pharmacy Valisure, which filed a citizen’s petition in September, calling on federal regulator to remove the drug from the market and provide instructions to consumers about the safe disposal of the medication to avoid widespread water contamination. The group also sent a copy of the petition to the World Health Organization, indicating that Zantac should be considered a human carcinogen.
According to independent testing by Valisure, levels of NDMA in one Zantac 150mg tablet may exceed 3,000,000 nanograms (ng), which is 26,000 times higher than the FDA’s permissible daily intake for the chemical.
Excessive levels were detected across all brands of Zantac and all lots, and Valisure indicated research dating back 20 years has included warning signs about potential problems with the drug.
While drug makers and federal regulators indicate that they are continuing to investigate the Zantac problems, many consumers are now questioning whether they may have avoided a cancer diagnosis if other available alternative treatments for heartburn had been used.
A growing number of Zantac lawsuits are now being pursued by individuals diagnosed with bladder cancer, stomach cancer, small intestine cancer, colorectal cancer, esophageal cancer and other problems impacting the digestive tract as NDMC from ranitidine moved through the body.