Drug product
S-B5/B6/B12M 100/50/10MG/ML MDV SOLN, 30ML glass vial, RX only, Red Mountain Compounding RX.
D-0204-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5x10 ml glass vials
- Official record key
drug-enforcement:D-0204-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S05132019DH@02, Exp 8/13/19; S05142019DT@05, Exp 8/14/19; S07032019DT@10, Exp 10/3/19; S07182019DH@01, Exp 10/18/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility