Drug product
PROCAINE 2% (PF), In a) 2ML Vials and b) 10ML Vials, MEDAUS PHARMACY
D-1232-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1500 mL in Vials
- Official record key
drug-enforcement:D-1232-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: a) Lot #: 160112-47, BUD: 07/10/16; Lot #: 160225-9, BUD: 08/23/16. b) Lot #: 160112-47, BUD: 07/10/16; Lot #: 160225-9, BUD: 08/23/16.
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility