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Recall Observatory FDA recall evidence

Drug product

Clonidine HCL PF 750 mcg/mL/Prialt PF (vial) 55 mcg/mL/Bupivacaine HCL PF 24 mg/mL *Compounded 20 mL Syringe (Standard) AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634 (800) 995-4363

D-0598-2020

September 03, 2019

Class II

Product summary

Firm
Coast Quality Pharmacy, LLC dba Anazao Health
Event
Event 83996
Status
Terminated
Classification
Class II
Quantity
Unknown
Official record key
drug-enforcement:D-0598-2020

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

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Controls