Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL, Compounded, 20 mL Syringe, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Reported: December 18, 2019 Initiated: September 3, 2019 #D-0599-2020
Product Description
Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL, Compounded, 20 mL Syringe, 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
- Recalling Firm
- Coast Quality Pharmacy, LLC dba Anazao Health
- Units Affected
- Unknown
- Distribution
- Nationwide in the U.S.
- Location
- Tampa, FL
Frequently Asked Questions
What product was recalled? ▼
Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL, Compounded, 20 mL Syringe, 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-0599-2020.
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