FDA recall D-0583-2020

Coast Quality Pharmacy, LLC dba Anazao Health · Class II · drug

Product

Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL in all strengths, all doses and all packaging, 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-0583-2020