FDA recall D-0465-2023

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2023-02-15

Report date

2023-03-22

Termination date

2024-04-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miramar, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0465-2023