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Recall Observatory FDA recall evidence

Drug product

Glutamine/Arginine/Carnitine in all strengths, all doses and all packaging, AnazaoHealth Corporate 5710 Hoover Blvd Tampa, FL 33634.

D-0579-2020

September 03, 2019

Class II

Product summary

Firm
Coast Quality Pharmacy, LLC dba Anazao Health
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

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Controls