FDA recall D-0600-2020

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

Product

Morphine Sulfate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging 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.

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-0600-2020