Drug product
S-METHYLCOBALAMIN 25MG/ML MDV INJ; 10ML glass vial, Rx Only, Red Mountain Compounding RX
D-0272-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2x30 ml glass vials
- Official record key
drug-enforcement:D-0272-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #:S05082019DT@16, Exp 8/8/19, S06052019DT@07, Exp 9/5/19;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility