Buprenorphine Transdermal System — Class III drug recall D-0465-2023
Terminated recall by AVEVA Drug Delivery Systems, Inc., reported 2023-03-22, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorph
| Recall number | D-0465-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVEVA Drug Delivery Systems, Inc., Miramar, FL, United States |
| Recall initiated | 2023-02-15 |
| Classified | 2023-03-14 |
| Reported by FDA | 2023-03-22 |
| Terminated | 2024-04-30 |
| Distributed | Nationwide (US) |
| Quantity | 11,520 cartons |
| Reason classes | specification failure |
| NDC | 60505-7077-05 |
| Lot numbers | 51835 |
| Expiration dates | 2023-06 |
Product
Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7077-05
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
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-0465-2023. 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.