The Recall Desk

FDA (Drugs) recall action 89356

Medique Products recalled 3 products on 2022-01-26

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2022-01-26
Critical
0
Units
26,530,356

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • ModerateFDA (Drugs)··2022-01-26

    Physicians CARE Extra Strength Pain Reliever recalled for CGMP deviations

    Medique Products is recalling Physicians CARE Extra Strength Pain Reliever tablets nationwide because they were not manufactured under Current Good Manufacturing Practices (CGMP), as determined by an FDA inspection.

    Product
    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
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-01-26

    Medique Pain-Off Tablets Recalled for Manufacturing Practice Violations

    Medique Products is recalling Medique Pain-Off tablets nationwide after an FDA inspection found the products were not manufactured under Current Good Manufacturing Practices.

    Product
    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
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-01-26

    Extra Strength Headache tablets recalled for CGMP manufacturing deviations

    Medique Products is recalling Extra Strength Headache tablets nationwide after an FDA inspection found they were not manufactured under Current Good Manufacturing Practices.

    Product
    Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404
    Category
    Distribution
    0 states