Drug product
S-DMSO 100% (PF) STERILE SOLUTION; packaged in a) 50 ml and b) 10 ml glass vials, Rx Only, Red Mountain Compounding Rx
D-0214-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10x50m ml and 1x10 ml glass vials
- Official record key
drug-enforcement:D-0214-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #:a) S04242019DT@15, Exp 10/24/19; S05012019DH@03, Exp 11/1/19; S05072019DT@10, Exp 11/7/19; S05072019DT@12, Exp 11/7/19; S06202019DT@03, Exp 12/20/19; S06202019DT@04, Exp 12/20/19; S07222019DH@05, Exp 07/22/2019 b) S06272019DT@06, Exp 12/27/19;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility