Drug product
B-COMPLEX #3 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 10ML Vials, MEDAUS PHARMACY
D-1168-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 380 mL in Vials
- Official record key
drug-enforcement:D-1168-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 160115-3, BUD: 06/11/16; Lot #: 160202-10, BUD: 06/11/16; Lot #: 160204-43, BUD: 06/11/16; Lot #: 160223-3, BUD: 06/11/16; Lot #: 160307-26, BUD: 06/11/16; Lot #: 160309-1, BUD: 06/11/16
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility