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Class II · ModerateRecall completed

Nizatidine

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot number06598004A 04/2020 06599001A 12/2020 06599002A 12/2020
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAmneal Pharmaceuticals LLC
Brand nameNIZATIDINE
Generic nameNIZATIDINE
Active ingredient(s)NIZATIDINE
Distributed by / forGemini Laboratories, LLC Bridgewater, NJ 08807
NDC60846-301-15
Show the full FDA record
Full product labelNizatidine 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
Recalling firmAmneal Pharmaceuticals of New York, LLC
DistributionNationwide
Quantity11258 bottles
Recall initiated2020-04-15
Report date2020-05-06
Recall completed2021-09-08
Recall numberD-1253-2020
ClassificationClass II
FDA statusTerminated
Origin on fileBrookhaven NY United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.