Drug product
B-COMPLEX W/CYANO B12 W/PRES., (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, CYANO B12 1MG/ML, In a) 2ML Vials, b) 5MLVials, c) 10ML Vials, MEDAUS PHARMACY
D-1174-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 62 mL in Vials
- Official record key
drug-enforcement:D-1174-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: a) Lot #: 160209-24, BUD: 05/28/16. b) Lot #: 160106-12, BUD: 05/28/16; Lot #: 160222-70, BUD: 05/28/16. c) Lot #: 160129-9, BUD: 05/28/16; Lot #: 160202-16, BUD: 05/28/16.
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility