Drug product
TESTOSTERONE CYP 100 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, and d) 5 ML Vials, MEDAUS PHARMACY
D-1241-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 mL in Vials
- Official record key
drug-enforcement:D-1241-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: a) Lot #: 160115-17, BUD: 07/13/16. b) Lot #: 160115-17, BUD: 07/13/16. c) Lot #: 160115-17, BUD: 07/13/16. d) Lot #: 160115-17, BUD: 07/13/16.
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility