Drug product
Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, packaged in 6.7 FL Oz. (200 mL) bottles, Distributed by: Access USA, Miami, FL 33308, UPC 650240025020
D-1548-2020
Product summary
- Event
- Event 86125
- Status
- Completed
- Classification
- Class II
- Quantity
- 17,280 bottles
- Official record key
drug-enforcement:D-1548-2020
Official wording
Reason: cGMP deviations
Code information: All lots.
Distribution pattern: AL, GA
Derived failure modes
-
Manufacturing or process control
cGMP deviations