CLASS II Drug recall · Reported 26 Jan 2022 · FDA Enforcement Report
Medique Pain-Off (Acetaminophen 250 mg, Aspirin recalled
Medique Products is recalling Medique Pain-Off (Acetaminophen 250 mg, Aspirin (Nsaid*) 250 mg, Caffeine 65 mg) Tablets, distributed nationwide in the US. The recall was initiated on 6 Dec 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0390-2022
- FDA event ID
- 89356
- Recalling firm
- Medique Products, Fort Myers, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Dec 2021
- FDA classified
- 20 Jan 2022
- Reported
- 26 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 6 Dec 2021 | Recall initiated by company | |
| 20 Jan 2022 | Classified by FDA | +45 days |
| 26 Jan 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Which lots are affected?
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 was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 89356This product is part of a recall event; the main page for the event is Physicians Care Extra Strength Pain Reliever [Acetaminophen recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Physicians Care Extra Strength Pain Reliever [Acetaminophen recalled | Medique Products | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Extra Strength Headache (acetaminophen 250 mg recalled | Medique Products | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Medique Products
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Extra Strength Headache (acetaminophen 250 mg recalled | Medique Products | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Physicians Care Extra Strength Pain Reliever [Acetaminophen recalled | Medique Products | Manufacturing (CGMP) Deviations | Nationwide |