Drug product
Glutamine/Arginine/Carnitine in all strengths, all doses and all packaging, AnazaoHealth Corporate 5710 Hoover Blvd Tampa, FL 33634.
D-0579-2020
Product summary
- Event
- Event 83996
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17 vials
- Official record key
drug-enforcement:D-0579-2020
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 09/24-26/2019 remaining within expiry.
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls