Drug product
S-ASCORBIC ACID 500MG/ML MDV SOLN (NON-CORN), packaged in a) 50ML, b) 5ML, c) 30ML, glass vial, RX Only, Red Mountain Compounding RX.
D-0199-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 81 vials
- Official record key
drug-enforcement:D-0199-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: a) S04112019DT@07,Exp 8/11/19; S05012019DT@01, 9/1/19; S05142019DT@13, 9/14/19; S05282019DT@07, 9/28/19; S06042019DT@05, 10/4/19; S06182019DH@15, 10/18/19; S07102019DT@13, 12/10/19; S07172019DT@09, 12/17/19 b) S04172019DT@01, 8/17/19; c) S07172019DT@09, 12/17/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility