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, Distribute by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.
D-0868-2022
Product summary
- Event
- Event 89879
- Status
- Completed
- Classification
- Class I
- Quantity
- 23,300 Unit Dose cups
- Official record key
drug-enforcement:D-0868-2022
Official wording
Reason: Microbial Contamination of Non-Sterile Products
Code information: Lot: 21067A, EXP Jun 2023
Distribution pattern: Distributed in Indiana for further distribution in the USA.
Derived failure modes
-
Microbial contamination
Microbial Contamination