Anazao Health Recalls Clonidine, Baclofen, and Fentanyl Citrate Due to Fungal Contamination
Anazao Health is recalling Clonidine HCL, Baclofen, and Fentanyl Citrate products due to the detection of Talaromyces rotundus fungi.
What this means for you
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 explicit high-risk pathogen designation.
Plain-English summary
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Clonidine HCL and Baclofen and Fentanyl Citrate in all strengths, doses, and packaging. 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, 2019, and August 29, 2019, and between September 27, 2019, 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 pharmacist or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Clonidine HCL and Baclofen 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 — 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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