Drug product
Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use Only, packaged in 100-count cartons of 10 trays x 10 unit dose cups, Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.
D-1879-2019
Product summary
- Event
- Event 83693
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1,433 cases
- Official record key
drug-enforcement:D-1879-2019
Official wording
Reason: Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.
Code information: Lots: 19027D, 19027E, Exp 07/21
Distribution pattern: One distributor who further distributed Nationwide in the USA.
Derived failure modes
-
Microbial contamination
Microbial Contamination