Anazao Health Recalls Morphine, Bupivacaine, and Clonidine Due to Fungal Contamination
Anazao Health is recalling specific lots of Morphine Sulfate, Bupivacaine HCL, and Clonidine 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a low-level fungal contamination (1 CFU) detected via environmental sampling, which aligns with the rubric for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Morphine Sulfate and Bupivacaine HCL and Clonidine HCL in all strengths, doses, and packaging. The recall is due to a lack of processing controls, as environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungus.
The affected products were filled and dispensed between August 26 and 29, 2019, and between September 27 and October 3, 2019, provided they remain within their expiration dates. These products were distributed nationwide in the U.S.
Consumers and healthcare providers should stop using the affected products and contact Anazao Health at (800) 995-4363 or visit 5710 Hoover Blvd, Tampa, FL 33634 for further instructions.
The recalled product
- Product
- Morphine Sulfate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634 (800) 995-4363
- Manufacturer
- Coast Quality Pharmacy, LLC dba Anazao Health
- Category
- Drug — Pharmacy Compounded
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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