Bupivacaine HCl and Hydromorphone HCl in all strengths — Class II drug recall D-0585-2020
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-0585-2020 |
|---|---|
| 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
Bupivacaine HCl and Hydromorphone 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-0585-2020. 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.