Recalls / Class II
Class IID-0563-2023
Product
Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 count) packets.
- Affected lot / code info
- SKUs a) 0901458; b) 0913023; c) 0999259 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
- Quantity
- Pending.
- 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-0563-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.