Why it was recalled
CGMP deviation: product outside labeled storage temperature requirements.
Product description
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles
Lot numbers, UPCs & expiration codes
SKUs 0902867 stored and distributed from DCs 07/28/2022 through 03/31/2023.
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-0565-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 31, 2023
- FDA report date
- May 10, 2023
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Family Dollar Stores, Llc.
Original FDA data
Every field from FDA enforcement report D-0565-2023, exactly as published.
Show all FDA fields
- City
- Chesapeake
- State
- VA
- Status
- Ongoing
- Country
- United States
- Event ID
- 92248
- Address
- 500 Volvo Pkwy
- Code information
- SKUs 0902867 stored and distributed from DCs 07/28/2022 through 03/31/2023.
- Postal code
- 23320-1604
- Report date
- May 10, 2023
- Product type
- Drugs
- Recall number
- D-0565-2023
- Classification
- Class II
- Recalling firm
- Family Dollar Stores, Llc.
- Reason for recall
- CGMP deviation: product outside labeled storage temperature requirements.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Mar 31, 2023
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 4, 2023