CLASS II Drug recall · Reported 26 Jan 2022 · FDA Enforcement Report
Physicians Care Extra Strength Pain Reliever [Acetaminophen recalled
Medique Products is recalling Physicians Care Extra Strength Pain Reliever [Acetaminophen, Aspirin (Nsaid), and, 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-0389-2022
- 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
Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, packaged as 100-count Tablets (50 Packets, 2 tablets each) per carton, Manufactured for: Acme United Corporation 55 Walls Dr, Fairfield, CT 06824, UPC 0 73577 90316 6
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, Carton) 6151, 4360 Exp. 10/2021; 6240, 4446 Exp. 12/2021; 6331, 4484 Exp. 02/2022; 6413, 4551 Exp. 04/2022; 6699, 4679 Exp. 10/2022; 6751, 4714 Exp. 12/2022; 6855, 4750 Exp. 01/2023; 6868, 4761 Exp. 02/2023; 6899, 4776 Exp. 02/2023; 6899, 4776 Exp. 02/2023; 7061, 4821 Exp. 05/2023.
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 89356| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Extra Strength Headache (acetaminophen 250 mg recalled | Medique Products | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Medique Pain-Off (Acetaminophen 250 mg, Aspirin recalled | Medique Products | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Medique Products
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Medique Pain-Off (Acetaminophen 250 mg, Aspirin recalled | Medique Products | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Extra Strength Headache (acetaminophen 250 mg recalled | Medique Products | Manufacturing (CGMP) Deviations | Nationwide |