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Recall Observatory FDA recall evidence

Drug product

MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6840-72.

D-1481-2022

June 07, 2022

Class II

Product summary

Firm
Plastikon Healthcare LLC
Event
Event 90398
Status
Terminated
Classification
Class II
Quantity
92,200 cups
Official record key
drug-enforcement:D-1481-2022

Official wording

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Code information: Lot # 20085A, EXP Aug. 2022; 20099A, EXP Oct. 2022; 21039A, 21052A, EXP May. 2023; 21114A, EXP Oct. 2023; 21130A, 21132A, EXP Dec. 2023.

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations