FDA recall D-0585-2020

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

Product

Bupivacaine 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-0585-2020