Drug product
CESIUM CHLORIDE 600MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
D-1177-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 506 mL in Vials
- Official record key
drug-enforcement:D-1177-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 151207-10, BUD: 06/04/16; Lot #: 151222-18, BUD: 06/19/16; Lot #: 151222-20, BUD: 06/19/16; Lot #: 160210-47, BUD: 08/29/16; Lot #: 160210-49, BUD: 08/29/16; Lot #: 160215-20, BUD: 08/13/16; Lot #: 160302-45, BUD: 08/29/16; Lot #: 160302-56, BUD: 08/29/16
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility