PlainRecalls
FDA Drug Moderate Class II Terminated

Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

Reported: December 18, 2019 Initiated: September 3, 2019 #D-0588-2020

Product Description

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.

Details

Units Affected
Unknown
Distribution
Nationwide in the U.S.
Location
Tampa, FL

Frequently Asked Questions

What product was recalled?
Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.. Recalled by Coast Quality Pharmacy, LLC dba Anazao Health. Units affected: Unknown.
Why was this product recalled?
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 18, 2019. Severity: Moderate. Recall number: D-0588-2020.