Drug product
RIC STOOL SOFTENER SOFTGEL 100 CT SKU 917000 RIC STOOL SOFTNER 100 CT SKU 902493 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
D-1421-2022
Product summary
- Event
- Event 90566
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-1421-2022
Official wording
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Code information: SKUs: 917000; 902493
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations