Medique Pain-Off Recall: FDA Class II

Why it was recalled

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

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 numbers, UPCs & expiration codes

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.

Where it was sold

Nationwide in the USA

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0390-2022
Classification: Class II
Status: Terminated
Recall initiated: Dec 6, 2021
FDA report date: Jan 26, 2022
Quantity: 16,630,118 tablets
Recall type: Voluntary: Firm initiated
Recalling firm: Medique Products

Original FDA data

Every field from FDA enforcement report D-0390-2022, exactly as published.

Show all FDA fields

City: Fort Myers
State: FL
Status: Terminated
Country: United States
Event ID: 89356
Address: 17080 Alico Commerce Ct Ste 1
Code information: 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.
Postal code: 33967-8509
Report date: Jan 26, 2022
Product type: Drugs
Recall number: D-0390-2022
Classification: Class II
Recalling firm: Medique Products
Product quantity: 16,630,118 tablets
Termination date: Jun 21, 2023
Reason for recall: CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Voluntary / mandated: Voluntary: Firm initiated
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.
Distribution pattern: Nationwide in the USA
Recall initiation date: Dec 6, 2021
Initial firm notification: Letter
Center classification date: Jan 20, 2022

Medique Pain-Off Recall

Summary