D-1253-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 6, 2020
- Initiation Date
- April 15, 2020
- Termination Date
- September 8, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11258 bottles
Product Description
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
Reason for Recall
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Distribution Pattern
Nationwide
Code Information
06598004A 04/2020 06599001A 12/2020 06599002A 12/2020