FDA Recall D-0565-2023
Family Dollar Stores, Llc. · Chesapeake, VA
Class II Ongoing 1140 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles
Reason for recall
CGMP deviation: product outside labeled storage temperature requirements.
Recall record
- Recall number
D-0565-2023- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide within the United States
- Recall initiated
- 2023-03-31
- Classified by FDA Center
- 2023-05-04
- FDA published
- 2023-05-10
- Recalling firm
- Family Dollar Stores, Llc.
- Firm location
- Chesapeake, VA
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.