Reported May 6, 2020 · Terminated
Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC…
Amneal Pharmaceuticals of New York, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Amneal Pharmaceuticals of New York, LLC · 50 Horseblock Rd · Brookhaven, NY · 11719-9509
Is this the product you have?
- Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles
- Rx Only Distributed byGemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15
- Lot codes and dates
- 06598004A 04/2020 06599001A 12/2020 06599002A 12/2020
- Amount recalled
- 11258 bottles
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
This product could cause temporary or reversible health problems — stop using it.
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