Drug product
HYDROXY B12 1000MCG/ML IN NACL 0.9% (PF), 1ML Vials, MEDAUS PHARMACY
D-1193-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 mL in Vials
- Official record key
drug-enforcement:D-1193-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 160104-64, BUD: 07/02/16
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility