April 15, 2020

Amneal Pharmaceuticals has issued a voluntary recall of its Nizatidine Oral Solution 15mg/mL (75mg/5mL) due to potential N-nitrosodimethylamine (NDMA) contamination. The product is packaged in 480mL bottles and distributed by Gemini Laboratories, a wholly owned subsidiary of Amneal Pharmaceuticals.

NDMA is considered a probable human carcinogen, meaning it may cause cancer if an individual has excessive exposure to the substance. The compound is a known environmental contaminant and has been at the center of numerous product recalls affecting “sartan” drugs and ranitidine products. The U.S. FDA has set interim limits on NDMA in medications. The recalled nizatidine contained NDMA in excess of these limits.

As of the date of the recall, no adverse effects had been reported related to the NDMA. Nizatidine oral solution is a prescription drug used to provide maintenance therapy and short-term treatment for ulcers, as well as to treat esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD).

Patients are advised to stop using the recalled nizatidine and contact Inmar for more information by phone at 1-855-319-4807 or by email at DrugSafety@amneal.com. If a patient experiences any problems that may be related to using the recalled product, they should contact their healthcare provider. Adverse reactions or quality issues can also be reported to the U.S. FDA’s MedWatch program, as well as to Amneal Drug Safety (1-877-835-5472 or DrugSafety@amneal.com).

Additional information, including affected lots and expiration dates, is available on the FDA’s website.

There is no member impact through Benecard Central Fill.

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