Drug product
RIBOFLAVIN 10MG/ML (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY
D-1237-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35 mL in Vials
- Official record key
drug-enforcement:D-1237-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: a) Lot #: 151123-74, BUD: 05/21/16; Lot #: 160315-10, BUD: 09/11/16. b) Lot #: 160204-21, BUD: 08/02/16.
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility