Drug product
FW ASPIRIN CHEWABLE TABLET 36CT SKU 913990 GS ENTERIC ASPIRIN TABLET 120 CT SKU 913724 BAYER BACK BODY EX STRGTH CAPLETS 24CT SKU 900438 BAYER LOW DOSE 81 MG TABLET 120 CT SKU 916070 BAYER ASPIRIN 325MG TABLET 24CT SKU 913996 BAYER LOW DOSE TABLET 32CT SKU 915641 BAYER 81MG CHEWABLE TABLET 36 CT SKU 916078 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
D-1424-2022
Product summary
- Event
- Event 90566
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-1424-2022
Official wording
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Code information: SKUs: 913990; 913724; 900438; 916070; 913996; 915641; 916078
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations