Drug product
TESTOSTERONE CYP 200 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML, and e) 5ML Vials, MEDAUS PHARMACY
D-1242-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8000 mL in Vials
- Official record key
drug-enforcement:D-1242-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: a) Lot #151210-5, BUD: 06/07/16; Lot #160204-31, BUD: 08/02/16; Lot #160107-8, BUD: 07/05/16; Lot #160303-47, BUD: 08/30/16. b) Lot #151210-5, BUD: 06/07/16; Lot #160107-8, BUD: 07/05/16; Lot #160204-31, BUD: 08/02/16; Lot #160303-47, BUD: 08/30/16. c) Lot #151207-8, BUD: 06/04/16; Lot #160303-47, BUD: 08/30/16; Lot #151210-5, BUD: 06/07/16; Lot #160107-8, BUD: 07/05/16; Lot #160204-31, BUD: 08/02/16; Lot #160106-34, BUD: 07/04/16; Lot#160208-22, BUD: 08/06/16. d) Lot #151210-5, BUD: 06/07/16; Lot #160107-8, BUD: 07/05/16; Lot #160204-31, BUD: 08/02/16; Lot #160303-47, BUD: 08/30/16. e) Lot #151210-5, BUD: 06/07/16; Lot #160107-8, BUD: 07/05/16; Lot #160204-31, BUD: 08/02/16; Lot #160303-47, BUD: 08/30/16.
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility