Why it was recalled
CGMP Deviations: product held outside appropriate storage temperature conditions.
Product description
NICORETTE GUM WHITE ICE MINT 4 MG 20 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Lot numbers, UPCs & expiration codes
SKU: 902014
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-1445-2022
- 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-1445-2022, 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
- SKU: 902014
- Postal code
- 23320-1604
- Report date
- Aug 31, 2022
- Product type
- Drugs
- Recall number
- D-1445-2022
- 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
- NICORETTE GUM WHITE ICE MINT 4 MG 20 CT 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