Drug product
B-COMPLEX W/METHYL B12/LIDO W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, LIDOCAINE 1%, METHYL B12 1MG/ML, In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
D-1175-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 370 mL in Vials
- Official record key
drug-enforcement:D-1175-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: a) Lot #: 151228-62, BUD: 06/25/16. b) Lot #: 160111-2, BUD: 06/11/16; Lot #: 160113-3, BUD: 06/11/16; Lot #: 160113-76, BUD: 06/11/16; Lot #: 160118-1, BUD: 06/11/16; Lot #: 160119-2, BUD: 06/11/16; Lot #: 160119-65, BUD: 06/11/16; Lot #: 160122-9, BUD: 06/11/16; Lot #: 160128-10, BUD: 06/11/16; Lot #: 160202-65, BUD: 06/11/16; Lot #: 160204-44, BUD: 06/11/16; Lot #: 160217-54, BUD: 06/11/16; Lot #: 160223-5, BUD: 06/11/16; Lot #: 160224-66, BUD: 06/11/16; Lot #: 160229-23, BUD: 06/11/16; Lot #: 160315-3, BUD: 06/11/16. c) Lot #: 160118-1, BUD: 06/11/16; Lot #: 160127-2, BUD: 06/11/16; Lot #: 160210-37, BUD: 06/11/16; Lot #: 160223-5, BUD: 06/11/16; Lot #: 160310-14, BUD: 06/11/16.
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility