Drug product
READY IN CASE PAIN RELIEVER PM CAPLET 100 CT SKU 902381 GOOD SENSE PAIN RELIEVER APAP 500MG CAPLET 250CT SKU 902332 READY IN CASE PM PAIN RELIEVER CAPLET 50 CT SKU 913982 GOOD SENSE PAIN RELIEVER APAP ES 500 CT SKU 999029 GOOD SENSE PAIN RELIEVER CAPLET 100 CT SKU 913890 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
D-1392-2022
Product summary
- Event
- Event 90566
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-1392-2022
Official wording
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Code information: SKUs: 902381; 902332; 913982; 999029; 913890
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations