Drug product
S-ESTRADIOL CYP 5MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10 ml, glass vials, Rx Only, Red Mountain Compounding RX
D-0218-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 5ml and 10ml glass vials
- Official record key
drug-enforcement:D-0218-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S05092019DH@08, Exp 8/9/19; S06112019DH@14, Exp 9/11/19; S07222019DH@04, Exp 10/22/19;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility