FDA recall D-0607-2020

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

Product

Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine 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-0607-2020