Drug product
S-MANGANESE CHLORIDE 0.1MG/ML MDV SOLN, 10 ML vial, Red Mountain Compounding Rx
D-0239-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2x10 ml vials
- Official record key
drug-enforcement:D-0239-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S05082019DT@01, Exp 9/8/19; S05222019DH@03, Exp 9/22/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility