Anazao Health Recalls Clonidine and Baclofen Due to Fungal Contamination
Anazao Health is recalling Clonidine HCL and Baclofen products because environmental sampling detected Talaromyces rotundus, a fungus.
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 contamination is described as a single CFU detected in environmental sampling, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Clonidine HCL and Baclofen in all strengths, doses, and packaging. The recall is due to a lack of processing controls, as environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
The affected products were filled and dispensed between 08/26-29/2019 and 09/27/2019 through 10/03/2019, provided they remain within their expiry date. The products were distributed nationwide in the U.S.
Consumers should stop using the recalled products and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Clonidine HCL 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 — Pharmacy Compounded
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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