Drug product
READY IN CASESLEEP AID SOFT GEL 32 CT SKU 901457 READY IN CASE SLEEP AID 64 CT SKU 999026 ZZZQUIL WARMING BERRY 12FL OZ SKU 999811 GOOD SENSESLEEP AID CAPLET 100 CT SKU 901496 GOOD SENSESLEEP AID CAPLET 24 CT SKU 913985 GOOD SENSE EZ NITE SLEEP BERRY 12FL OZSKU 999789 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
D-1393-2022
Product summary
- Event
- Event 90566
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-1393-2022
Official wording
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Code information: SKUs: 901457; 999026; 999811; 901496; 913985; 999789
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations