Reported May 25, 2022 · Completed

Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10…

Plastikon Healthcare LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Plastikon Healthcare LLC · 3780 Greenway Cir · Lawrence, KS · 66046-5440

Is this the product you have?

    • 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
  • NDC0904-6838-73
Lot codes and dates
  • Lot
    • 20042A
    • 20043A
    • 20045A
    • 20046A
    • 20047A
    • EXP May 2022
Amount recalled
106,400 Unit Dose cups

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

Why it was recalled

CGMP Deviations: Failure to properly investigate failed microbial testing.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:02 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.