Recalls / Class II
Class IID-1393-2022
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.
- Affected lot / code info
- SKUs: 901457; 999026; 999811; 901496; 913985; 999789
Why it was recalled
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recalling firm
- Firm
- Family Dollar Stores, Llc.
- Notification channel
- Other
- Type
- Voluntary: Firm initiated
- Address
- 500 Volvo Pkwy, Chesapeake, Virginia 23320-1604
Distribution
- Quantity
- Unknown
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-06-23
- FDA classified
- 2022-08-22
- Posted by FDA
- 2022-08-31
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1393-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.