Drug product
METHYL B12 1000MCG/ML/PYRIDOXINE 100MG W/PRES. (BENZALKONIUM 0.01%), In a) 1ML Vials and b) 10ML Vials, MEDAUS PHARMACY
D-1215-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 mL in Vials
- Official record key
drug-enforcement:D-1215-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: a) Lot #: 160222-85, BUD: 07/05/16. b) Lot #: 160222-85, BUD: 07/05/16.
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility