Amneal Pharmaceuticals has announced a nationwide recall of Nizatidine Oral Solution over concerns the medication may contain Nitrosodimethylamine (NDMA) – a probable human carcinogen – above guidelines established by the U.S. Food & Drug Administration (FDA).
Nizatidine is indicated to treat heartburn symptoms associated with GERD and esophagitis. It is considered an equipotent of ranitidine, the active ingredient in Zantac, but has a slightly different chemical makeup.
The U.S. Environmental Protection Agency has designated NDMA a probable human carcinogen, as tests involving lab animals suggest exposure to high levels may increase the risk of cancer, especially tumors of the gastrointestinal tract, kidneys and liver. A known environmental contaminant, NDMA is found in water and foods, including meats, dairy products and vegetables
Amneal Pharmaceutical’s recall affects Nizatidine Oral Solution 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles and distributed by the company’s Gemini Laboratories, LLC subsidiary. These products can be identified by NDC No. 60846-301-15 and include:
Amneal has not received any adverse event reports related to the Nizatidine recall.
Consumers who have the affected products in their possession should stop taking the drug and call 1-855-319-4807, Monday – Friday, 8:00 am – 5:00 pm, EST for further information.
Patients who experience any problems that might be related to the use of Amneal’s recalled Nizatidine are advised to contact their physician or healthcare provider. Adverse events may also be reported to Amneal Drug Safety at 1-877-835-5472, Monday thru Friday, 8:00 am – 6:00 pm, EST, or to the FDA MedWatch program.
The FDA has been investigating the presence of NDMA in Zantac and generic ranitidine products since last September, when the online pharmacy Valisure disclosed that it had detected the compound in every sample it tested and often at levels that far exceeded the agency’s recommended daily limit of 96 nanograms.
Valisure’s tests also suggested that the unstable ranitidine molecule actually produced NDMA when subjected to conditions similar to human digestion. Earlier this year, Emery Pharma revealed that its own tests indicated ranitidine produced NDMA when subjected to high temperatures typically encountered during shipment and storage.
Even before the FDA concluded its investigation, Valisure’s findings had prompted multiple drug makers to announce ranitidine and Zantac recalls. Most major retailers also stopped selling the medications. Earlier this month, the FDA confirmed that NDMA in ranitidine can increase over time and ordered an immediate Zantac recall for all name-brand and generic versions remaining on the market.