Drug product
S-METHYLCOBALAMIN 5,000MCG/ML MDV Injection, 30 ML glass vial, Rx Only, Red Mountain Compounding RX
D-0273-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28x30 ml glass vials
- Official record key
drug-enforcement:D-0273-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S07022019DT@09, Exp 10/2/19; S05082019DT@08, Exp 8/8/19; S06042019DT@07, Exp 9/4/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility