PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 26, 2022 Initiated: December 6, 2021 #D-0391-2022

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

Reason for Recall

CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.

Details

Recalling Firm
Medique Products
Units Affected
6,639,838 tablets
Distribution
Nationwide in the USA
Location
Fort Myers, FL

Frequently Asked Questions

What product was recalled?
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. Recalled by Medique Products. Units affected: 6,639,838 tablets.
Why was this product recalled?
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 26, 2022. Severity: Moderate. Recall number: D-0391-2022.