Anazao Health Recalls Multi-Drug Compounded Formulations Due to Fungal Contamination
Anazao Health is recalling compounded hydromorphone, bupivacaine, baclofen, clonidine, and fentanyl products due to the detection of Talaromyces rotundus fungi.
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, and the hazard is a low-level fungal contamination (1 CFU) without reported adverse health consequences.
Plain-English summary
Coast Quality Pharmacy, LLC dba Anazao Health is recalling all strengths, doses, and packaging of compounded formulations containing Hydromorphone HCL, Bupivacaine HCL, Baclofen, Clonidine HCL, and Fentanyl Citrate. The recall was initiated because environmental sampling revealed the presence of Talaromyces rotundus, a type of fungi, indicating a lack of processing controls.
The affected products were filled and dispensed between August 26 and August 29, 2019, and between September 27 and October 3, 2019. The recall covers 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 healthcare provider or pharmacist for guidance on proper disposal or replacement.
The recalled product
- Product
- 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.
- 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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