Drug product
S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass vial, Rx Only, Red Mountain Compounding RX.
D-0217-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3x50ml, 6x100ml glass vials
- Official record key
drug-enforcement:D-0217-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: a) S04232019DT@07, Exp 8/23/19; S07302019DH@09, Exp 11/30/19, b) S05142019DT@14, Exp 9/14/19; S06182019DH@30, Exp 10/18/19; S06182019DH@13, Exp 10/18/19;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility