Recalls / Class II
Class IID-0566-2023
Product
Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Capsule bottles; b) 40-count Liquid Filled Capsule bottles.
- Affected lot / code info
- SKUs a) 0999841; b) 0916071 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-0566-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.