Drug product
NA ASCORBATE 500MG/ML NON-CORN (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vials, MEDAUS PHARMACY
D-1229-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 358000 mL in Vials
- Official record key
drug-enforcement:D-1229-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: a) Lot #: 151201-30, BUD: 05/29/16; Lot #: 151209-26, BUD: 06/06/16; Lot #: 151216-63, BUD: 06/13/16; Lot #: 151231-11, BUD: 06/28/16; Lot #: 160105-4, BUD: 07/03/16; Lot #: 160125-41, BUD: 07/23/16; Lot #: 160211-20, BUD: 08/09/16. b) Lot #: 151201-30, BUD: 05/29/16; Lot #: 151209-26, BUD: 06/06/16; Lot #: 151216-63, BUD: 06/13/16; Lot #: 151231-11, BUD: 06/28/16; Lot #: 160105-4, BUD: 07/03/16; Lot #: 160125-41, BUD: 07/23/16; Lot #: 160511-20, BUD: 08/09/16. c) Lot #: 151201-30, BUD: 05/29/16; Lot #: 151209-26, BUD: 06/06/16; Lot #: 151216-63, BUD: 06/13/16; Lot #: 151231-11, BUD: 06/28/16; Lot #: 160105-4, BUD: 07/03/16; Lot #: 160125-41, BUD: 07/23/16; Lot #: 160511-20, BUD: 08/09/16.
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility