BUP 5MG/ HYDROM 15MG/ SUF 600MCG/ML — Class II drug recall D-0712-2020
Terminated recall by Assurance Infusion, reported 2020-01-22, distributed nationwide. Lack of sterility assurance.
| Recall number | D-0712-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Assurance Infusion, Houston, TX, United States |
| Recall initiated | 2019-12-20 |
| Classified | 2020-01-13 |
| Reported by FDA | 2020-01-22 |
| Terminated | 2021-10-27 |
| Distributed | Nationwide (US) |
| Quantity | 2 syringes |
| Reason classes | sterility |
| Expiration dates | 2019-12-19 |
Product
BUP 5MG/ HYDROM 15MG/ SUF 600MCG/ML (40ML) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Reason for recall
Lack of sterility assurance.
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-0712-2020. 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.