Drug product
NA ASCORBATE 500MG/ML (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vials, MEDAUS PHARMACY
D-1228-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 157,500 mL in Vials
- Official record key
drug-enforcement:D-1228-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: a) Lot #: 151217-47, BUD: 06/14/16; Lot #: 160112-51, BUD: 07/10/16; Lot #: 160127-43, BUD: 07/25/16; Lot #: 160218-8, BUD: 08/16/16; Lot #: 151211-26, BUD: 06/08/16. b) Lot #: 151211-26, BUD: 06/08/16; Lot #: 151217-47, BUD: 06/14/16; Lot #: 160112-51, BUD: 07/10/16; Lot #: 160127-43, BUD: 07/25/16; Lot #: 160218-8, BUD: 08/16/16. c) Lot #: 151211-26, BUD: 06/08/16; Lot #: 160112-51, BUD: 07/10/16; Lot #: 160127-43, BUD: 07/25/16; Lot #: 151217-47, BUD: 06/14/16; Lot #: 160218-8, BUD: 08/16/16.
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility