Drug product
Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL, Compounded, 20 mL Syringe, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
D-0599-2020
Product summary
- Event
- Event 83996
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-0599-2020
Official wording
Reason: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Code information: All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls