Drug 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
D-1253-2020
Product summary
- Event
- Event 85386
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11258 bottles
- Official record key
drug-enforcement:D-1253-2020
Official wording
Reason: CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Code information: 06598004A 04/2020 06599001A 12/2020 06599002A 12/2020
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations