Amneal Pharmaceuticals of New York, LLC recalls Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Brid
Recalled May 6, 2020 · FDA recall D-1253-2020 · Amneal Pharmaceuticals of New York
Hazard
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. · FDA Class II
Units
11258 bottles
Sold at
Nationwide
Description
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
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
Manufacturer(s)
Amneal Pharmaceuticals of New York, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →