FDAFDA · Food and drugs·Recall number D-1253-2020
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
Published May 6, 2020 · Recall initiated: April 15, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Brand
- NIZATIDINE
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Distributor
- Nationwide
- Lot
- 06598004A 04/2020 06599001A 12/2020 06599002A 12/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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