Drug product
NIACINAMIDE 100 MG/ML (PF), In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
D-1231-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 104 mL in Vials
- Official record key
drug-enforcement:D-1231-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: a) Lot #: 160204-29, BUD: 08/02/16. b) Lot #: 151123-73, BUD: 05/21/16; Lot #: 151124-42, BUD: 05/22/16; Lot #: 151201-20, BUD: 05/29/16; Lot #: 151215-10, BUD: 06/12/16; Lot #: 160229-46, BUD: 07/17/16; Lot #: 160202-33, BUD: 07/31/16. c) Lot #: 160315-9, BUD: 09/11/16.
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility