Coast Quality Pharmacy, LLC dba Anazao Health recalls Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL, Compounded, 20 mL Syringe, A…

Recall date

September 3, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0599-2020

FDA classification

Class II

Brand / firm

Coast Quality Pharmacy, LLC dba Anazao Health

Sold / distributed

Nationwide in the U.S.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.