FDA Recalls Anazao Health Hydromorphone, Clonidine, and Fentanyl Combination Drugs
Anazao Health is recalling specific lots of hydromorphone, clonidine, and fentanyl combination drugs due to fungal contamination found during environmental sampling.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the presence of a fungal contaminant in a drug product.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate 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 due to a lack of processing controls. Environmental sampling identified 1 Colony Forming Unit (CFU) of Talaromyces rotundus, a type of fungus. The affected products were filled and dispensed between August 26 and August 29, 2019, and between September 27 and October 3, 2019, provided they remain within their expiration dates.
These products were distributed nationwide in the United States. Patients who have received these specific medications should contact their healthcare provider or pharmacist for guidance on discontinuing use and obtaining alternative treatment.
The recalled product
- Product
- Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate 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 — Combination Injectable
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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