Drug product
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
D-0252-2026
Product summary
- Event
- Event 98131
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 570 bottles
- Official record key
drug-enforcement:D-0252-2026
Official wording
Reason: cGMP Deviations
Code information: Lot #: 250505P9, Exp. Date 05/27
Distribution pattern: AZ only
Derived failure modes
-
Manufacturing or process control
cGMP Deviations