Drug product
DEXPANTHENOL 250MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY
D-1179-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1110 mL in Vials
- Official record key
drug-enforcement:D-1179-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 160204-45, BUD: 06/14/16; Lot #: 160210-38, BUD: 06/14/16; Lot #: 160215-9, BUD: 06/14/16; Lot #: 160222-16, BUD: 06/14/16; Lot #: 160223-6, BUD: 06/14/16; Lot #: 160229-74, BUD: 06/14/16; Lot #: 160302-31, BUD: 06/14/16; Lot #: 160307-27, BUD: 06/14/16
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility