Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplet
Summary
The FDA issued a Class II for Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) by Family Dollar Stores, Llc.. Reason: CGMP deviation: product outside labeled storage temperature requirements..
Details
Source
Drug Recall
External ID
D-0565-2023
Action Date
2023-05-10
Status
Ongoing
Category
drug
Product Description
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles
Lot/Code Info: SKUs 0902867 stored and distributed from DCs 07/28/2022 through 03/31/2023.
Reason for Recall
CGMP deviation: product outside labeled storage temperature requirements.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-31
Company
Chesapeake, VA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 45 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Family Dollar Stores, Llc. has 149 FDA actions in our database, including 149 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Family Dollar Stores, Llc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Family Dollar Stores, Llc. have FDA actions?
Family Dollar Stores, Llc. has 149 FDA actions in our database, including 149 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0565-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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