Drug product
METHYL B12 5MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY
D-1218-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 600 mL in Vials
- Official record key
drug-enforcement:D-1218-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 151123-25, BUD: 05/21/16; Lot #: 160126-12, BUD: 07/24/16
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility