Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottle
Summary
The FDA issued a Class II for Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in by Family Dollar Stores, Llc.. Reason: CGMP deviation: product outside labeled storage temperature requirements..
Details
Source
Drug Recall
External ID
D-0563-2023
Action Date
2023-05-10
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: SKUs a) 0901458; b) 0913023; c) 0999259 stored and distributed from DCs 07/28/2022 through 03/31/2023.
Quantity Affected: Pending.
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-0563-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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