Drug product
All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar.
D-1104-2023
Product summary
- Event
- Event 92884
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-1104-2023
Official wording
Reason: CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled Products may have been subjected to temperatures in excess of storage condition instructions on product labeling.
Code information: Miscellaneous
Distribution pattern: Separate Distribution List (salvage buyers) provided by Inmar and will be uploaded. Final customer distribution unknown.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations