Drug product
B-COMPLEX 50 IN NACL 0.9% W/PRES., (BENZYL ETOH 2%), B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 10ML Vials, MEDAUS PHARMACY
D-1173-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4000 mL in Vials
- Official record key
drug-enforcement:D-1173-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 151220-4, BUD: 06/17/16; Lot #: 160216-31, BUD: 08/14/16
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility