Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Buprenorphine Transdermal System Recalled by AVEVA Drug Delivery Systems, Inc. Due to Failed Impurities/Degradation Specifications: Out of specification for related...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact AVEVA Drug Delivery Systems, Inc. directly.
Affected Products
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
Quantity: 11,520 cartons
Why Was This Recalled?
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About AVEVA Drug Delivery Systems, Inc.
AVEVA Drug Delivery Systems, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report