Drug product
TESTOSTERONE CYP 20 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials and b) 3ML Vials, MEDAUS PHARMACY
D-1243-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 mL in Vials
- Official record key
drug-enforcement:D-1243-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: a) Lot #: 160302-71, BUD: 08/29/16. b) Lot #: 151207-8, BUD: 06/04/16; Lot #: 160106-34, BUD: 07/04/16; Lot #: 160208-22, BUD: 08/16/16.
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility