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-0870-2022
Product summary
- Event
- Event 89879
- Status
- Completed
- Classification
- Class II
- Quantity
- 5,400 Unit Dose cups
- Official record key
drug-enforcement:D-0870-2022
Official wording
Reason: CGMP Deviations: Failure to properly investigate failed microbial testing.
Code information: Lot: 20041A, EXP May 2022
Distribution pattern: Distributed in Indiana for further distribution in the USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations