Drug product
S-CYANOCOBALAMIN 1,000 MCG/ML MDV INJ SOLN, packaged in a) 10ml and b) 30 ml glass vial, Rx Only, Red Mountain Compounding Rx.
D-0209-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5x10 ml and 5x30 ml glass vials
- Official record key
drug-enforcement:D-0209-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: a) S05312019DT@03, Exp 8/31/19;S06032019DT@05, Exp 9/3/19 S06122019DT@07, Exp 9/12/19; b) S05312019DT@07, Exp 8/31/19; S06122019DT@07, Exp 9/12/19;S06252019DH@11, Exp 9/25/19; S07172019DT@01, Exp 10/25/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility