FDA recall D-0599-2020

Product

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.

Reason for recall

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

Distribution

Nationwide in the U.S.

Key facts

Status

Terminated

Initiation date

2019-09-03

Report date

2019-12-18

Termination date

2020-12-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tampa, FL, United States

Primary source

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