Anazao Health Recalls Bupivacaine, Clonidine, and Hydromorphone Combination Injections
Coast Quality Pharmacy is recalling Bupivacaine, Clonidine, and Hydromorphone injections due to fungal contamination found 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, but the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Bupivacaine HCL and Clonidine 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 are all lots filled on August 26, 2019, and dispensed between August 26 and August 29, 2019, that remain within their expiration dates. The products were distributed nationwide in the U.S.
Consumers and healthcare providers should stop using the recalled products and contact their pharmacist or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Bupivacaine HCL and Clonidine 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 — Injectable Medication
- 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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