Drug product
METHYL B12 10MG/ML W/PRES (BENZALKONIUM 0.01%) IN NACL 0.9%, In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
D-1219-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 331 mL in Vials
- Official record key
drug-enforcement:D-1219-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: a) Lot #: 160201-11, BUD: 07/11/16; Lot #: 160215-13, BUD: 07/11/16; Lot #: 160309-4, BUD: 07/11/16. b) Lot #: 160315-1, BUD: 07/11/16; Lot #: 160201-11, BUD: 07/11/16; Lot #: 160210-71, BUD: 07/11/16; Lot #: 160309-4, BUD: 07/11/16. c) Lot #: 160125-17, BUD: 07/11/16; Lot #: 160210-35, BUD: 07/11/16; Lot #: 160222-20, BUD: 07/11/16; Lot #: 160204-46, BUD: 07/11/16; Lot #: 160307-25, BUD: 07/11/16.
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility