FDAFDA · Food and drugs·Recall number D-0465-2023
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
Published March 22, 2023 · Recall initiated: February 15, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AVEVA Drug Delivery Systems, Inc.
- Distributor
- Nationwide
- Lot
- Lot#: 51835 Exp: 06/2023
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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