Drug product
M.I.C B-COMPLEX W/PRES. (BENZYL ETOH 2%) B1-50MG;B2-5-PO4-5MG;B3-50MG;B5-5MG;B6-5MG; CYANO B12 100MCG; CHOLINE CHL-50MG; INOSITOL-25MG;METHIONINE 12.5MG/ML, 5ML Vials, MEDAUS PHARMACY
D-1223-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1430 mL in Vials
- Official record key
drug-enforcement:D-1223-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 160119-59; BUD: 05/26/16, Lot #: 151228-72; BUD: 05/26/16, Lot #: 160127-4; BUD: 05/26/16, Lot #: 160201-13; BUD: 05/26/16, Lot #: 160202-13; BUD: 05/26/16, Lot #: 160204-11; BUD: 05/26/16, Lot #: 160202-66; BUD: 06/11/16, Lot #: 160307-31; BUD: 06/11/16, Lot #: 160224-68; BUD: 06/11/16, Lot #: 160205-8; BUD: 06/11/16
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility