Drug product
S-DMSO 6.25% OPTH SOLN, 10 ml dropper bottle, Rx Only, Red Mountain Compounding Rx
D-0260-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7x10 ml dropper bottles
- Official record key
drug-enforcement:D-0260-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #:S05082019ST@05, Exp 8/8/19; S05212019DT@08, Exp 8/21/19; S05312019DT@10, Exp 8/31/19; S06272019DT@03, Exp 9/27/19; S07222019DH@06, Exp 10/22/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility