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Recall Observatory FDA recall evidence

Drug product

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

D-0589-2020

September 03, 2019

Class II

Product summary

Firm
Coast Quality Pharmacy, LLC dba Anazao Health
Event
Event 83996
Status
Terminated
Classification
Class II
Quantity
Unknown
Official record key
drug-enforcement:D-0589-2020

Official wording

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

Code information: All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.

Distribution pattern: Nationwide in the U.S.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Controls