FDA Recalls Hydromorphone HCL Due to Fungal Contamination
Coast Quality Pharmacy is recalling Hydromorphone HCL 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. The source text does not report any illnesses or injuries, and the contamination is described as a single CFU detected in environmental sampling, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Hydromorphone HCL in all strengths, doses, and packaging. The recall is being conducted by Coast Quality Pharmacy, LLC dba Anazao Health, located in Tampa, Florida.
The recall was initiated due to a lack of processing controls. Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a type of fungus. The affected lots were filled on August 26, 2019, and dispensed between August 26 and August 29, 2019, provided they remain within their expiration date. The product was distributed nationwide in the U.S.
Consumers who have this medication should contact their healthcare provider or pharmacist for guidance on how to dispose of the product or obtain a replacement. The FDA classifies this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Hydromorphone 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 — 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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