Drug product
ESTRADIOLVAL 3MG/TEST CYP 35MG/ TEST PROP 35MG/ML W/PRES. (BENZYL ETOH 2%), 3ML Vials, MEDAUS PHARMACY
D-1183-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 mL in Vials
- Official record key
drug-enforcement:D-1183-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 151218-14, BUD: 06/15/16
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility