Drug product
M.I.C./B-COMPLEX (PF) B1-50MG;B2-5-PO4-5MG;B3-50MG;B6-5MG; CYANO B12 100MCG; CHOLINE CHL-5MG; INOSITOL-25MG;METHIONINE 12.5MG/ML, 2ML Vials, MEDAUS PHARMACY
D-1221-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3000 mL in Vials
- Official record key
drug-enforcement:D-1221-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 151220-5, BUD: 05/26/16; Lot #: 160127-25, BUD: 07/25/16
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility