Drug product
LIDOCAINE 2% (PF) IN NACL, 10ML Vials, MEDAUS PHARMACY
D-1200-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 147 mL in Vials
- Official record key
drug-enforcement:D-1200-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 151203-48, BUD: 05/31/16; Lot #: 151204-9, BUD: 06/01/16; Lot #: 151218-20, BUD: 06/15/16; Lot #: 160125-23, BUD: 07/23/16; Lot #: 160125-24, BUD: 07/23/16; Lot #: 160125-25, BUD: 07/23/16; Lot #: 160127-6, BUD: 07/25/16; Lot #: 160302-76, BUD: 08/29/16; Lot #: 160302-77, BUD: 08/29/16
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility