Drug product
Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 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: 0904-6838-73.
D-0871-2022
Product summary
- Event
- Event 89879
- Status
- Completed
- Classification
- Class II
- Quantity
- 106,400 Unit Dose cups
- Official record key
drug-enforcement:D-0871-2022
Official wording
Reason: CGMP Deviations: Failure to properly investigate failed microbial testing.
Code information: Lot: 20042A, 20043A, 20045A, 20046A, 20047A, EXP May 2022
Distribution pattern: Distributed in Indiana for further distribution in the USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations