FDA Drug recall D-0466-2023
Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva…
- FDA Drug
- Class III
- terminated
- Published 2023-03-22
On 2023-03-22 the FDA classified a Class III recall of Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva… by Aveva Drug Delivery Systems, citing failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0466-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-02-15 |
| Published | 2023-03-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aveva Drug Delivery Systems |
| Distribution | US |
Product
Buprenorphine Transdermal System, CIII 20 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 60505-7079-05
Reason
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Identifiers
| code_info | Lot#: 51836 Exp: 07/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0466-2023%22
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