Amneal Pharmaceuticals Recalls Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL)

Amneal Pharmaceuticals, Bridgewater, NJ, announced on April 15, 2020 that it was recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles and distributed by Gemini Laboratories, because of potential N-Nitrosodimethylamine (NDMA) contamination.

Nizatidine Oral Solution is used for the short-term treatment of ulcers and esophagitis and associated heartburn due to gastroesophageal reflux disease. NDMA is classified as a probable human carcinogen and is a known environmental contaminant found in water and foods.

The affected Nizatidine Oral Solution lots were distributed directly to wholesalers and then were distributed to retail pharmacies and consumers nationwide in the United States. The company has not received any reports of adverse effects. Adverse events may be reported to FDA through its MedWatch program.