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
Product summary
- 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
CGMP Deviations