Drug product
B-COMPLEX WITHOUT B12 (PF) IN NACL 0.9%, B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY
D-1170-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4000 mL in Vials
- Official record key
drug-enforcement:D-1170-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: a) Lot #: 151130-66, BUD: 05/28/16; Lot #: 160222-51, BUD: 08/20/16. b) Lot #: 151130-60, BUD: 05/28/16; Lot #: 160222-51, BUD: 08/20/16.
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility