Drug product
HYDROXY B12 5MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY
D-1190-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 210 mL in Vials
- Official record key
drug-enforcement:D-1190-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 160202-12, BUD: 07/11/16; Lot #: 160204-10, BUD: 07/11/16; Lot #: 160210-70, BUD: 07/11/16; Lot #: 160215-11, BUD: 07/11/16; Lot #: 160222-17, BUD: 07/11/16; Lot #: 160223-64, BUD: 07/11/16; Lot #: 160224-67, BUD: 07/11/16; Lot #: 160307-28, BUD: 07/11/16; Lot #: 160308-1, BUD: 07/11/16; Lot #: 160309-3, BUD: 07/11/16
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility