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
Reported: March 22, 2023 Initiated: February 15, 2023 #D-0465-2023
Product Description
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.
Details
- Recalling Firm
- AVEVA Drug Delivery Systems, Inc.
- Units Affected
- 11,520 cartons
- Distribution
- Nationwide
- Location
- Miramar, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by AVEVA Drug Delivery Systems, Inc.. Units affected: 11,520 cartons.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 22, 2023. Severity: Low. Recall number: D-0465-2023.
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