Drug product
NIACIN 250MG 110; NDC/UPC 740985228494; OTC; TABLETS
D-0401-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 bottles
- Official record key
drug-enforcement:D-0401-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: All Lots distributed 02/23/2021 through 03/10/2021.
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations