Drug product
METHYL B12 10MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY
D-1216-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1000 mL in Vials
- Official record key
drug-enforcement:D-1216-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 160118-31, BUD: 07/16/16
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility