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Recall Observatory FDA recall evidence

Drug 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.

D-0867-2022

March 24, 2022

Class I

Product summary

Firm
Plastikon Healthcare LLC
Event
Event 89879
Status
Completed
Classification
Class I
Quantity
14,100 Unit Dose cups
Official record key
drug-enforcement:D-0867-2022

Official wording

Reason: Microbial Contamination of Non-Sterile Products

Code information: Lot: 20024A, 20025A, EXP Mar 2022

Distribution pattern: Distributed in Indiana for further distribution in the USA.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination