Anazao Health Recalls Hydromorphone and Clonidine Due to Fungal Contamination
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Hydromorphone HCL and Clonidine HCL products because environmental sampling detected Talaromyces rotundus, a fungus.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a low-level fungal contamination (1 CFU) detected via environmental sampling, which fits the criteria for a moderate, precautionary recall without reported harm.
Plain-English summary
Coast Quality Pharmacy, LLC dba Anazao Health is voluntarily recalling all strengths, doses, and packaging of Hydromorphone HCL and Clonidine HCL. The recall was initiated after environmental sampling at the facility identified 1 CFU (Colony Forming Unit) of Talaromyces rotundus, a type of fungus.
The affected products were filled and dispensed between August 26, 2019, and August 29, 2019, and between September 27, 2019, and October 3, 2019. The recall includes all lots remaining within their expiration dates. The products were distributed nationwide in the United States.
Consumers who have these products should stop using them and contact their pharmacist or the recalling firm for instructions on disposal or replacement. This recall is classified as FDA Class II, indicating a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Hydromorphone HCL and Clonidine HCL 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 — Pharmacy Compounded
- 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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