Drug product
S-HYDROXOCOBALAMIN 1000MCG/ML MDV INJ; packaged in a) 10ML b) 30ML glass vial, Red Mountain Compounding Rx
D-0268-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0268-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #:a) S07162019DT@04, Exp 10/16/19; b) S07162019DT@04 Exp 10/16/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility