FDA-Drug2019-12-18Class II

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.

Coast Quality Pharmacy, LLC dba Anazao Health
Hazard

Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.

Sold states
Nationwide in the U.S.
Affected count
Unknown
Manufactured in
5710 Hoover Blvd, N/A, Tampa, FL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0599-2020

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