FDA Drug Class II — Moderate

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

Hazard

Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.

Products

Hydromorphone HCL and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Brand
Coast Quality Pharmacy, LLC dba Anazao Health
UPC
All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.

Units Affected

Unknown