Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets, packaged in 2-count Tablets pe
Summary
The FDA issued a Class II for Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) 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-0390-2022
Action Date
2022-01-26
Status
Terminated
Category
drug
Product Description
Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets, packaged in 2-count Tablets per Unit Dose Packet, packaged as a) 200-count Tablets (100 x 2) Unit Dose packets per carton, UPC 3 47682 22847 7, Reorder #22847; b) 500-count Tablets (250 x 2) Unit Dose packets per carton, UPC 3 47682 22813 2, Reorder #22813; c) 100-count Tablets (50 x 2) Unit Dose packets per carton, UPC 3 47682 22833 0, Reorder #22833; d) 24-count Tablets (12 x 2) Unit Dose packets per carton, UPC 3 47682 22864 4, Reorder #22864; Manufactured for Medique Products, Fort Myers, FL 33967.
Lot/Code Info: Lots: (packet lot, carton lot) a) 7062, 10611 Exp. 05/2023; 7062, 10110 Exp. 05/2023; 7062, 10067 Exp. 05/2023; 6414, 07378 Exp. 04/2022; 6700, 08047 Exp. 10/2022; 6152, 05553 Exp. 10/2022; 6239, 07120 Exp. 12/2021; 6239, 06504 Exp. 12/2021; 6152, 05737 Exp. 10/2021; 6700, 08653 Exp. 10/2022; 6330, 07217 Exp. 02/2022; 6414, 07360 Exp. 04/2022; 6749, 08717 Exp. 12/2022; 6794, 09012 Exp. 12/2022; b) 6856, 09108 Exp. 01/2023; 6867, 09460 Exp. 02/2023; 6900, 10105 Exp. 02/2023; 6749, 09139 Exp. 12/2022; 6152, 05944 Exp. 10/2021; 6152, 05483 Exp. 10/2021; 6414, 07488 Exp. 04/2022; 6493, 07662 Exp. 06/2022; 6414, 07286 Exp. 04/2022; 6493, 07709 Exp. 06/2022; 6414, 07524 Exp. 04/2022; 6330, 06728 Exp. 02/2022; 6330, 06366 Exp. 02/2022; 6239, 06503 Exp. 12/2021; 6330, 06460 Exp. 02/2022; c) 7070, 10605 Exp. 06/2023; 7063, 11089 Exp. 06/2023; 7070, 11020 Exp. 06/2023; 6867, 09545 Exp. 02/2023; 7062, 10066 Exp. 05/2023; 6749, 08650 Exp. 12/2022; 6493, 07784 Exp. 06/2022; 6493, 07920 Exp. 06/2022; 6330, 06949 Exp. 02/2022; 6239, 06945 Exp. 12/2021; 6239, 05973 Exp. 12/2021; 6152, 05687 Exp. 10/2021; 6493, 07950 Exp. 06/2022; 6493, 07825 Exp. 06/2022; d) 7062, 10265 Exp. 05/2023; 7070, 10980 Exp. 06/2023; 6867, 09607 Exp. 02/2023; 6152, 06039 Exp. 10/2021; 6330, 07121 Exp. 02/2022; 6700, 08040 Exp. 10/2022; 6493, 07985 Exp. 06/2022; 6152, 05783 Exp. 10/2021; 6749, 08866 Exp. 12/2022.
Quantity Affected: 16,630,118 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-0390-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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