OTC Pain Relievers Recalled

Medique Products is recalling acetaminophen-aspirin-caffeine tablets sold as Extra Strength Headache and Medique Pain-Off tablets because they were not manufactured under Current Good Manufacturing Practices, according to the January 26, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects more than 6 million Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count packets, from lots 6492 (Exp. 6/22), 6701 (Exp. 10/22), 6750 (Exp. 12/22), 6853 (Exp. 1/23), 6854 (Exp. 1/23), 6869 (Exp. 2/23), 6898 (Exp. 2/23), 6901 (Exp. 2/23), 7059 (Exp. 5/23), 7060 (Exp. 5/23), 7064 (Exp. 6/23), and 7065 (Exp. 6/23). The tablets were manufactured for Lil’ Drug Store Products Inc, Cedar Rapids, IA, and distributed throughout the United States.

The recall also includes more than 16 million Medique Pain-Off (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count packets, in

• 200-tablet cartons (UPC 3 47682 22847 7), from lots (packet lot, carton lot) 7062, 10611 (Exp. 5/23); 7062, 10110 (Exp. 5/23); 7062, 10067 (Exp. 5/23); 6414, 07378 (Exp. 4/22); 6700, 08047 (Exp. 10/22); 6152, 05553 (Exp. 10/22); 6239, 07120 (Exp. 12/21); 6239, 06504 (Exp. 12/21); 6152, 05737 (Exp. 10/21); 6700, 08653 (Exp. 10/22); 6330, 07217 (Exp. 2/22); 6414, 07360 (Exp. 4/22); 6749, 08717 (Exp. 12/22); and 6794, 09012 (Exp. 12/22);
• 500-tablet cartons (UPC 3 47682 22813 2) from lots (packet lot, carton lot) 6856, 09108 (Exp. 1/23); 6867, 09460 (Exp. 2/23); 6900, 10105 (Exp. 2/23); 6749, 09139 (Exp. 12/22); 6152, 05944 (Exp. 10/21); 6152, 05483 (Exp. 10/21); 6414, 07488 (Exp. 4/22); 6493, 07662 (Exp. 6/22); 6414, 07286 (Exp. 4/22); 6493, 07709 (Exp. 6/22); 6414, 07524 (Exp. 4/22); 6330, 06728 (Exp. 2/22); 6330, 06366 (Exp. 2/22); 6239, 06503 (Exp. 12/21); and 6330, 06460 (Exp. 2/22);
• 100-tablet cartons (UPC 3 47682 22833 0) from lots (packet lot, carton lot) 7070, 10605 (Exp. 6/23); 7063, 11089 (Exp. 6/23); 7070, 11020 (Exp. 6/23); 6867, 09545 (Exp. 2/23); 7062, 10066 (Exp. 5/23); 6749, 08650 (Exp. 12/22); 6493, 07784 (Exp. 6/22); 6493, 07920 (Exp. 6/22); 6330, 06949 (Exp. 2/22); 6239, 06945 (Exp. 12/21); 6239, 05973 (Exp. 12/21); 6152, 05687 (Exp. 10/21); 6493, 07950 (Exp. 6/22); and 6493, 07825 (Exp. 6/22); and
• 24-tablet cartons (UPC 3 47682 22864 4) from lots (packet lot, carton lot) 7062, 10265 (Exp. 5/23); 7070, 10980 (Exp. 6/23); 6867, 09607 (Exp. 2/23); 6152, 06039 (Exp. 10/21); 6330, 07121 (Exp. 2/22); 6700, 08040 (Exp. 10/22); 6493, 07985 (Exp. 6/22); 6152, 05783 (Exp. 10/21); and 6749, 08866 (Exp. 12/22).

The Medique Pain-Off tablets were manufactured for Medique Products, Fort Myers, FL, and distributed throughout the United States.

Medique Products voluntarily initiated the recalls December 6, 2021. On January 20, 2022, the FDA designated the recalls Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

The medications are available over the counter for temporary relief from minor aches and pains.