Drug product
TESTOSTERONE CYP 50 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML Vials, and e) 5ML Vials, MEDAUS PHARMACY
D-1245-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 150 mL in Vials
- Official record key
drug-enforcement:D-1245-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: a) Lot #: 160119-12, BUD: 07/17/16. b) Lot #: 160119-12, BUD: 07/17/16. c) Lot #: 160119-12, BUD: 07/17/16. d) Lot #: 160119-12, BUD: 07/17/16. e) Lot #: 160119-12, BUD: 07/17/16.
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility