Drug product
HYDROXY B12 1000MCG/ML W/PRES (BENZALKONIUM 0.01%), 10ML Vials, MEDAUS PHARMACY
D-1192-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7000 mL in Vials
- Official record key
drug-enforcement:D-1192-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 151221-56, BUD: 06/18/16; Lot #: 160203-23, BUD: 08/01/16; Lot #: 160218-45, BUD: 08/16/16
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility