Drug product
Hydromorphone HCL and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
D-0591-2020
Product summary
- Event
- Event 83996
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-0591-2020
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