Drug product
BENZEFOAM EMOLLIENT FOAM BENZOYL PEROXIDE 5.3% 100GM TOP EMOL NDC 187-0194--10; OTC; FOAMS
D-0444-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 carton
- Official record key
drug-enforcement:D-0444-2021
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