Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged ...
FDA Recall #D-0391-2022 — Class II — December 6, 2021
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.
Recalling Firm
Medique Products — Fort Myers, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
6,639,838 tablets
Distribution
Nationwide in the USA
Code Information
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated