Drug product
THIAMINE 100 MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY
D-1247-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 213 mL in Vials
- Official record key
drug-enforcement:D-1247-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 160129-2, BUD: 06/07/16; Lot #: 160201-10, BUD: 06/07/16; Lot #: 160222-19, BUD: 06/07/16; Lot #: 160215-12, BUD: 06/07/16; Lot #: 160315-2, BUD: 06/07/16
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility