Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per
Summary
The FDA issued a Class II for Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) t by Medique Products. Reason: CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practi.
Details
Source
Drug Recall
External ID
D-0391-2022
Action Date
2022-01-26
Status
Terminated
Category
drug
Product Description
Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404
Lot/Code Info: Lots: 6492 Exp. 06/2022; 6701 Exp. 10/2022; 6750 Exp. 12/2022; 6853 Exp. 01/2023; 6854 Exp. 01/2023; 6869 Exp. 02/2023; 6898 Exp. 02/2023; 6901 Exp. 02/2023; 7059 Exp. 05/2023; 7060 Exp. 05/2023; 7064 Exp. 06/2023; 7065 Exp. 06/2023
Quantity Affected: 6,639,838 tablets
Reason for Recall
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-06
Company
Fort Myers, FL
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 44 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Medique Products has 3 FDA actions in our database, including 3 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 (Medique Products) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medique Products have FDA actions?
Medique Products has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0391-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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