Drug product
S-ESTRADIOL VALERATE 20MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10ml, glass vial, RX Only, Red Mountain Compounding RX.
D-0219-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2x5ml, 1x10 ml glass vials
- Official record key
drug-enforcement:D-0219-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S07232019DH@10, Exp 10/23/19; S08012019DH@03, Exp 11/1/19;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility