Recall D-0465-2023
Description: 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
Recall D-0465-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0465-2023 |
| Event ID | 91712 |
| Distribution | Nationwide |
| Quantity | 11,520 cartons |
| Recall Reason | Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint. |
| Drug Classification | Class III |
| Drug Code Info | 20230322 |
| Recall Initiation Date | 20230215 |
| Report Date | 20230322 |
| Classification Date | 20230314 |
| Address | 3250 Commerce Pkwy Miramar, FL 33025-3907 United States |
| Recalling Firm | AVEVA Drug Delivery Systems, Inc. |
| Initial Notification | Letter |
| Similar To |