Drug product
METHYL B12 1000MCG/ML W/PRES (BENZALKONIUM 0.01% IN NACL 0.9%, In a) 2ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
D-1214-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8020 mL in Vials
- Official record key
drug-enforcement:D-1214-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: a) Lot #: 151218-30, BUD: 06/15/16; Lot #: 151221-70, BUD: 06/18/16. b) Lot #: 151221-78, BUD: 06/18/16; Lot #: 160217-40, BUD: 08/15/16. c) Lot #: 151221-78, BUD: 06/18/16; Lot #: 160217-40, BUD: 08/15/16.
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility