Anazao Health Recalls Fentanyl and Morphine Compounded Medications
Anazao Health is recalling compounded fentanyl and morphine medications due to the detection of Talaromyces rotundus fungi in environmental samples.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and Baclofen in all strengths, doses, and packaging. The recall was initiated because environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi, indicating a lack of processing controls.
The affected products were filled and dispensed between August 26 and 29, 2019, and September 27 and October 3, 2019, and are distributed nationwide in the U.S. Consumers should check their medication for these specific dates and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
- Manufacturer
- Coast Quality Pharmacy, LLC dba Anazao Health
- Category
- Drug — Compounded Medication
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 31 recalled by Coast Quality Pharmacy, LLC dba Anazao Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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