Drug product
ORAJEL GUM PAIN RELIEF GEL 0.125OZ SKU 903432 GOOD SENSE ORAL PAIN RELIEF 0.5OZ SKU 999543 ORAJEL ORAL PAIN 0.125 FL OZ SKU 912968 ORAJEL MOUTH SORE GEL 0.125 OZ SKU 999075 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
D-1381-2022
Product summary
- Event
- Event 90566
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-1381-2022
Official wording
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Code information: SKUs: 903432; 999543; 912968; 999075
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations