Recalls / Class II
Class IID-0565-2023
Product
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles
- Affected lot / code info
- SKUs 0902867 stored and distributed from DCs 07/28/2022 through 03/31/2023.
Why it was recalled
CGMP deviation: product outside labeled storage temperature requirements.
Recalling firm
- Firm
- Family Dollar Stores, Llc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 500 Volvo Pkwy, Chesapeake, Virginia 23320-1604
Distribution
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-03-31
- FDA classified
- 2023-05-04
- Posted by FDA
- 2023-05-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0565-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.