Anazao Health Recalls Compounded Clonidine Syringes Due to Fungal Contamination
Anazao Health is recalling compounded Clonidine, Prialt, and Bupivacaine syringes 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 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 a fungal contamination (Talaromyces rotundus) in a compounded injectable drug, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Coast Quality Pharmacy, LLC dba Anazao Health is recalling compounded 20 mL syringes containing Clonidine HCL, Prialt, and Bupivacaine HCL. The recall was initiated because environmental sampling revealed the presence of Talaromyces rotundus, a fungus, indicating a lack of processing controls.
The affected products were filled and dispensed between August 26 and August 29, 2019, and from September 27 through October 3, 2019. The recall covers all lots remaining within their expiration dates. These products were distributed nationwide in the United States.
Consumers who have these specific compounded syringes should stop using them and contact Anazao Health at (800) 995-4363 or their healthcare provider for further instructions.
The recalled product
- Product
- Clonidine HCL PF 750 mcg/mL/Prialt PF (vial) 55 mcg/mL/Bupivacaine HCL PF 24 mg/mL *Compounded 20 mL Syringe (Standard) AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634 (800) 995-4363
- Manufacturer
- Coast Quality Pharmacy, LLC dba Anazao Health
- Category
- Drug — Compounded 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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