Why it was recalled
CGMP Deviations: product held outside appropriate storage temperature conditions.
Product description
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.
Lot numbers, UPCs & expiration codes
SKUs: 901457; 999026; 999811; 901496; 913985; 999789
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1393-2022
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 23, 2022
- FDA report date
- Aug 31, 2022
- Quantity
- Unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Family Dollar Stores, Llc.
Original FDA data
Every field from FDA enforcement report D-1393-2022, exactly as published.
Show all FDA fields
- City
- Chesapeake
- State
- VA
- Status
- Ongoing
- Country
- United States
- Event ID
- 90566
- Address
- 500 Volvo Pkwy
- Code information
- SKUs: 901457; 999026; 999811; 901496; 913985; 999789
- Postal code
- 23320-1604
- Report date
- Aug 31, 2022
- Product type
- Drugs
- Recall number
- D-1393-2022
- Classification
- Class II
- Recalling firm
- Family Dollar Stores, Llc.
- Product quantity
- Unknown
- Reason for recall
- CGMP Deviations: product held outside appropriate storage temperature conditions.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jun 23, 2022
- Initial firm notification
- Other
- Center classification date
- Aug 22, 2022