Anazao Health Recalls Fentanyl and Morphine Compounded Drugs Due to Fungal Contamination
Anazao Health is recalling compounded fentanyl and morphine drugs after environmental sampling detected Talaromyces rotundus fungi.
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. According to the rubric, an FDA Class II recall involving a significant hazard (fungal contamination of injectable drugs) without explicit reports of hospitalization or death falls under the 'Severe' category (Score 4), as it represents a significant risk of harm.
Plain-English summary
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Fentanyl Citrate and Bupivacaine HCl and Morphine Sulfate in all strengths, doses, and packaging. The recall is due to a lack of processing controls, which resulted in environmental sampling revealing 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
The affected products were filled on August 26, 2019, and dispensed between August 26 and August 29, 2019, provided they remain within their expiry date. The products were distributed nationwide in the U.S.
Consumers who have these products should stop using them and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- Fentanyl Citrate and Bupivacaine HCl and Morphine Sulfate 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 — Compounded Injectable
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.
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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