Drug product
TAURINE 50 MG/ML (PF), In a) 1ML Vials, b) 10ML Vials, and c) 20ML Vials, MEDAUS PHARMACY
D-1239-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5500 mL in Vials
- Official record key
drug-enforcement:D-1239-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: a) Lot #: 151202-54, BUD: 05/30/16; Lot #: 160308-31, BUD: 09/04/16. b) Lot #: 151202-54, BUD: 05/30/16; Lot #: 160308-31, BUD: 09/04/16. c) Lot #: 151202-54, BUD: 05/30/16; Lot #: 160308-31, BUD: 09/04/16.
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility