Date: 04/15/2020
Product: Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15
Company: Amneal Pharmaceuticals of New York, LLC
Recall Reason: CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Classification: Class II
Report Date: 20200506