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Recall Observatory FDA recall evidence

Drug product

MILK OF MAGNESIA USP, 2400 mg/30 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 0904-6846-73.

D-1480-2022

June 07, 2022

Class II

Product summary

Firm
Plastikon Healthcare LLC
Event
Event 90398
Status
Terminated
Classification
Class II
Quantity
502,600 cups
Official record key
drug-enforcement:D-1480-2022

Official wording

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

Code information: Lot # 20072A, 20075A, EXP Jul. 2022; 20087A, EXP Aug. 2022; 20089A, 20090A, EXP Sep. 2022; 20100A, 20102A, EXP Oct. 2022; 20106A, 20107A EXP Nov. 2022; 20109A, EXP Dec. 2022; 21010A, EXP Jan. 2023; 21028A, 21030A, 21032A, EXP Mar. 2023; 21045A, 21046A, EXP Apr. 2023; 21054A, EXP May. 2023; 21078A, 21079A, 21085A, EXP Jul. 2023; 21088A, EXP Aug. 2023

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations