Anazao Health Recalls Compounded Sufentanil Syringes Due to Fungal Contamination
Coast Quality Pharmacy, LLC dba Anazao Health is recalling compounded sufentanil, clonidine, and bupivacaine syringes because environmental sampling detected Talaromyces rotundus.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 and involves fungal contamination of a compounded drug, which fits the rubric criteria for Severe severity.
Plain-English summary
Coast Quality Pharmacy, LLC dba Anazao Health is recalling specific lots of Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL, Compounded, 20 mL Syringes. The recall is due to a lack of processing controls, as environmental sampling revealed the presence 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. The recall includes all remaining units within their expiration dates. The products were distributed nationwide in the U.S.
Patients who have received these syringes should contact their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL, Compounded, 20 mL Syringe, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
- Manufacturer
- Coast Quality Pharmacy, LLC dba Anazao Health
- Category
- Drug — Compounded 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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