FDA-Drug2020-05-06Class II
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
Amneal Pharmaceuticals of New York, LLC
Hazard
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Sold states
Nationwide
Affected count
11258 bottles
Manufactured in
50 Horseblock Rd, N/A, Brookhaven, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1253-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief