AVEVA Drug Delivery Systems, Inc. recalls Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manu
Recalled March 22, 2023 · FDA recall D-0466-2023 · AVEVA Drug Delivery Systems
Hazard
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint. · FDA Class III
Units
5,208 cartons
Sold at
Nationwide
Description
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
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
Manufacturer(s)
AVEVA Drug Delivery Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →