Coast Quality Pharmacy, LLC dba Anazao Health recalls Clonidine HCL PF 750 mcg/mL/Prialt PF (vial) 55 mcg/mL/Bupivacaine HCL PF 24 mg/mL *Compounded 20 mL Syringe (Standard)…

Recall date

September 3, 2019

Source

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

Recall number

D-0598-2020

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

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