Drug product
PYRIDOXINE HCL 100MG/ML W/PRES (BENZYL ETOH 0.02%), 5ML Vials, MEDAUS PHARMACY
D-1236-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4000 mL in Vials
- Official record key
drug-enforcement:D-1236-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 151220-6, BUD: 06/17/16, Lot #: 160225-7, BUD: 08/23/16
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility