Anazao Health Recalls Bupivacaine and Hydromorphone Due to Fungal Contamination
Anazao Health is recalling Bupivacaine HCl and Hydromorphone HCl 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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Bupivacaine HCl and Hydromorphone HCl in all strengths, doses, and packaging. The recall is due to a lack of processing controls and environmental sampling that identified Talaromyces rotundus, a fungus.
The affected products were filled on August 26, 2019, and dispensed between August 26 and August 29, 2019. The recall includes all lots remaining within their expiry dates. The products were distributed nationwide in the U.S.
Consumers should stop using the recalled products and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- Bupivacaine HCl and 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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