PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: December 18, 2019 Initiated: September 3, 2019 #D-0598-2020

Product Description

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

Reason for Recall

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

Details

Units Affected
Unknown
Distribution
Nationwide in the U.S.
Location
Tampa, FL

Frequently Asked Questions

What product 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. Recalled by Coast Quality Pharmacy, LLC dba Anazao Health. Units affected: Unknown.
Why was this product recalled?
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 18, 2019. Severity: Moderate. Recall number: D-0598-2020.