Drug product
MINOXIDIL 0.5% W/PRES. (BENZYL ETOH 2%), 10ML Vials, MEDAUS PHARMACY
D-1226-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21000 mL in Vials
- Official record key
drug-enforcement:D-1226-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 151130-64, BUD: 05/28/16, Lot #: 151228-22, BUD: 06/25/16, Lot #: 160210-29, BUD: 08/08/16
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility