Anazao Health Recalls Hydromorphone and Bupivacaine Combination Injections
Anazao Health is recalling hydromorphone and bupivacaine combination injections due to the presence of Talaromyces rotundus fungi detected 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, and the contamination is described as a single CFU detected during environmental sampling, fitting the criteria for a low-risk contamination or voluntary precautionary recall.
Plain-English summary
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, doses, and packaging. The recall is being conducted because environmental sampling revealed the presence of 1 CFU (Colony Forming Unit) of Talaromyces rotundus, a type of fungi, indicating a lack of processing controls.
The affected products were filled and dispensed between August 26 and 29, 2019, and between September 27 and October 3, 2019. The recall covers all lots remaining 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 further instructions.
The recalled product
- Product
- Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine 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
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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