Pain Patches Recalled

Aveva Drug Delivery Systems Inc is recalling 2 lots of buprenorphine transdermal systems for failing to meet impurity/degradation specifications. According to the March 22, 2023, US Food and Drug Administration (FDA) Enforcement Report, the product was “out of specification for related substance 10-hydroxy buprenorphine N-oxide … at the 18-month stability timepoint.”

The recall affects the following products, which were manufactured by Aveva Drug Delivery Systems, Miramar, Florida, for Apotex Corp, Weston, Florida, and distributed throughout the United States:

• buprenorphine transdermal system 10 mcg/hour, 4 transdermal systems, 4 disposal units (NDC 60505-7077-05), from lot 51835 (Exp. 6/23); and
• buprenorphine transdermal system, 20 mcg/hour, 4 transdermal systems, 4 disposal unit (NDC 60505-7079-05), from lot 51836 (Exp. 7/23).

Aveva Drug Delivery Systems voluntarily initiated the recall February 15, 2023. The FDA designated the recall Class III on March 14, 2023. Under the recall classification, use of the product is not likely to cause harm.

Buprenorphine transdermal systems are a Schedule III prescription medication indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.