Drug product
GERMANIUM SESO 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
D-1187-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49 mL in Vials
- Official record key
drug-enforcement:D-1187-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 151229-21, BUD: 06/26/16; Lot #: 151229-25, BUD: 06/26/16; Lot #: 151229-31, BUD: 06/26/16; Lot #: 160126-14, BUD: 07/24/16
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility