Baclofen Recalled by Anazao Health Due to Fungal Contamination
Anazao Health is recalling Baclofen products after environmental sampling detected Talaromyces rotundus, a type of 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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Baclofen in all strengths, doses, and packaging. The recall was initiated because environmental sampling revealed the presence of 1 CFU (Colony Forming Unit) of Talaromyces rotundus, a fungus, indicating a lack of processing controls.
The affected products were filled on August 26, 2019, and dispensed between August 26 and August 29, 2019. These products are distributed nationwide in the U.S. and remain within their expiration dates.
Consumers should stop using the recalled Baclofen products and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- 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 — Pharmaceutical
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.
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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