FDA Recalls Hydromorphone and Bupivacaine Due to Fungal Contamination
Coast Quality Pharmacy is recalling Hydromorphone HCL and Bupivacaine HCL products due to the detection of Talaromyces rotundus fungi during environmental sampling.
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, which typically involves a temporary or medically reversible adverse health consequence. The source text does not report any illnesses, injuries, or fatalities, and the hazard is identified through environmental sampling rather than confirmed patient harm, fitting the criteria for a moderate severity score.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Hydromorphone HCL and Bupivacaine 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 because environmental sampling revealed the presence of Talaromyces rotundus, a type of fungi. This finding indicates a lack of processing controls in the manufacturing or handling environment. The affected products include all lots filled on August 26, 2019, and dispensed between August 26 and August 29, 2019, that remain within their expiration dates.
These products were distributed nationwide in the United States. Consumers and healthcare providers should stop using these specific products and contact their pharmacist or the recalling firm for further instructions on disposal or replacement.
The recalled product
- Product
- Hydromorphone HCL and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
- Manufacturer
- Coast Quality Pharmacy, LLC dba Anazao Health
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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