Class II · Moderate risk Ongoing
fentaNYL Citrate
Reason Subpotent Drug
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
What was recalled
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
- Recalling firm
- Coast Quality Pharmacy, LLC dba Anazao Health
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0606-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Fentanyl recalls
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Class II · Moderate risk Ongoing
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
Reason cGMP deviations.
Class II · Moderate risk Ongoing
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
Reason cGMP deviations.
Class II · Moderate risk Ongoing
fentaNYL Citrate Injectable Solution
Reason cGMP deviations.
Class II · Moderate risk Ongoing
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride
Reason cGMP deviations.
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