Class II · Moderate risk
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Medique Pain-Off
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
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.
Drug: Acetaminophen Category: Pain Relief & OTC Medication
- Recalling firm
- Medique Products
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0390-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Acetaminophen recalls
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Class II · Moderate risk
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II · Moderate risk
Tylenol
Defective Container
Class II · Moderate risk
Acetaminophen 500mg Caffeine 65mg caplets
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Class II · Moderate risk
Acetaminophen Injection 1000 mg/100 mL
Discoloration
Other recalls by Medique Products
All 2021 recalls
Class II · Moderate risk
Extra Strength Headache
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Class II · Moderate risk
Physicians CARE Extra Strength PAIN RELIEVER
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
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