AVEVA Drug Delivery Systems, Inc.: Drug Recall

Recall #D-0465-2023 · 02/15/2023

Class III: Low Risk

Recall Details

Recall Number: D-0465-2023
Classification: Class III
Product Type: Drug
Recalling Firm: AVEVA Drug Delivery Systems, Inc.
Status: Terminated
Date Initiated: 02/15/2023
Location: Miramar, FL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 11,520 cartons

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.

Product 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

Distribution Pattern

Nationwide

Other Recalls by AVEVA Drug Delivery Systems, Inc.

Class III: Low Risk 02/15/2023

Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.

View all recalls by AVEVA Drug Delivery Systems, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.