Recalls / Class II
Class IID-1253-2020
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
- Brand name
- Nizatidine
- Generic name
- Nizatidine
- Active ingredient
- Nizatidine
- Route
- Oral
- NDC
- 60846-301
- FDA application
- ANDA090576
- Affected lot / code info
- 06598004A 04/2020 06599001A 12/2020 06599002A 12/2020
Why it was recalled
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Recalling firm
- Firm
- Amneal Pharmaceuticals of New York, LLC
- Manufacturer
- Amneal Pharmaceuticals LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 50 Horseblock Rd, N/A, Brookhaven, New York 11719-9509
Distribution
- Quantity
- 11258 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2020-04-15
- FDA classified
- 2020-04-24
- Posted by FDA
- 2020-05-06
- Terminated
- 2021-09-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1253-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.