May 08, 2020
Amneal Pharmaceuticals of New York is recalling three lots of nizatidine oral solution due to potential contamination with N-Nitrosodimethylamine (NDMA), a probable human carcinogen. The recall was included in the May 6, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 480-mL bottles of nizatidine oral solution, 15 mg/mL (75 mg/5mL, NDC 60846-301-15), from lots 06598004A (Exp. 4/20), 06599001A (Exp. 12/20), and 06599002A (Exp. 12/20). The lots were distributed by Gemini Laboratories, a subsidiary of Amneal Pharmaceuticals.
“The affected nizatidine oral solution lots were distributed directly to wholesalers, who further distributed to retail pharmacies and consumers nationwide in the United States,” stated an April 15, 2020, news release from the company.
Amneal Pharmaceuticals initiated the voluntary recall April 15, 2020. The FDA designated the recall Class II on April 24, 2020, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Nizatidine is a prescription medication used for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease, or GERD.