Why it was recalled
CGMP Deviations: product held outside appropriate storage temperature conditions.
Product description
Ready in case ACETAMINOPHEN PM CAPLETS 24 CT SKU 900559; TYLENOL CHILD GRAPE 4 FL OZ SKU 901600 TYLENOL CHILD ORAL SUSPENSION CHERRY 4 FO 913104 TYLENOL INFANTS DROPS DF CHERRY 1OZ SKU 999108 TYLENOL PM CAPLET 24 CT SKU 900603 TYLENOL EXTRA STRENGTH CAPLET 24 CT SKU 916986 TYLENOL 8HR MSL ACHE PAIN RD CAPLET 24 CT SKU 901155 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Lot numbers, UPCs & expiration codes
SKUs:900559; 901600; 913104; 999108; 900603; 916986; 901155
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-1372-2022
- 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-1372-2022, 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:900559; 901600; 913104; 999108; 900603; 916986; 901155
- Postal code
- 23320-1604
- Report date
- Aug 31, 2022
- Product type
- Drugs
- Recall number
- D-1372-2022
- 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 case ACETAMINOPHEN PM CAPLETS 24 CT SKU 900559; TYLENOL CHILD GRAPE 4 FL OZ SKU 901600 TYLENOL CHILD ORAL SUSPENSION CHERRY 4 FO 913104 TYLENOL INFANTS DROPS DF CHERRY 1OZ SKU 999108 TYLENOL PM CAPLET 24 CT SKU 900603 TYLENOL EXTRA STRENGTH CAPLET 24 CT SKU 916986 TYLENOL 8HR MSL ACHE PAIN RD CAPLET 24 CT SKU 901155 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