Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL in all… — Class II drug recall D-0604-2020
Terminated recall by Coast Quality Pharmacy, LLC dba Anazao Health, reported 2019-12-18, distributed nationwide. Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talarom
| Recall number | D-0604-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Coast Quality Pharmacy, LLC dba Anazao Health, Tampa, FL, United States |
| Recall initiated | 2019-09-03 |
| Classified | 2019-12-06 |
| Reported by FDA | 2019-12-18 |
| Terminated | 2020-12-01 |
| Distributed | Nationwide (US) |
| Reason classes | microbial contamination |
| Pathogens | mold |
Product
Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Reason for recall
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0604-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.