Drug product
PEPCID COMPLETE CHEWABLE TAB BERRY 8CT SKU 903365 PEPCID AC MAXIMUM STRENGTH TABLET 25 CT SKU 902063 PEPCID AC MAXIMUM STRENGTH TABLET 8 CT SKU 914773 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
D-1419-2022
Product summary
- Event
- Event 90566
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-1419-2022
Official wording
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Code information: SKUs: 903365; 902063; 914773
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations