The Recall Desk

FDA (Drugs) recall action 89879

Plastikon Healthcare LLC recalled 5 products on 2022-05-25

The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2022-05-25
Critical
0
Units
271,000

Why these products were recalled

Microbial Contamination of Non-Sterile Products

CGMP Deviations: Failure to properly investigate failed microbial testing.

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.

States named across these recalls

1–5 of 5

  • SevereFDA (Drugs)··2022-05-25

    Antacid suspension product recalled due to microbial contamination

    Plastikon Healthcare LLC is recalling 23,300 antacid suspension cups due to microbial contamination. The product was distributed in Indiana for institutional use.

    Product
    Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distribute by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2022-05-25

    Milk of Magnesia USP Recalled for Microbial Contamination

    Plastikon Healthcare LLC is recalling Milk of Magnesia USP (2400 mg/30 mL) distributed in Indiana due to microbial contamination in this non-sterile product. The FDA classified this as a Class I recall.

    Product
    MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2022-05-25

    Antacid Suspension Recalled for Failed Microbial Testing

    Plastikon Healthcare LLC is recalling antacid suspension due to manufacturing quality control failures. The company failed to properly investigate results from microbial testing.

    Product
    Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2022-05-25

    Acetaminophen Oral Solution Recalled Due to Manufacturing Quality Control Failure

    Plastikon Healthcare LLC is recalling Acetaminophen Oral Solution due to failure to properly investigate failed microbial testing. The recall affects 121,800 unit dose cups distributed in Indiana.

    Product
    Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2022-05-25

    Milk of Magnesia Institutional Units Recalled for Manufacturing Quality Deviation

    Plastikon Healthcare LLC is recalling 5,400 unit doses of Milk of Magnesia USP (Lot 20041A, exp. May 2022) due to failure to properly investigate failed microbial testing during manufacturing. The product was distributed in Indiana for further distribution nationwide.

    Product
    MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.
    Category
    Distribution
    1 state