Buprenorphine Transdermal System 20 mcg/hour Recalled for Specification Failure
AVEVA Drug Delivery Systems recalls Buprenorphine Transdermal System 20 mcg/hour (Lot 51836) nationwide due to degradation product impurity exceeding specification limits during stability testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III classification and absence of reported adverse events limit the maximum severity to 2 or lower. This pharmaceutical specification failure represents a quality defect warranting precautionary recall, placing it in the Moderate category rather than Low, consistent with voluntary precautionary recalls per the rubric.
Plain-English summary
AVEVA Drug Delivery Systems, Inc. and Apotex Corp are recalling Buprenorphine Transdermal System, CIII 20 mcg/hour in packages of 4 units (NDC 60505-7079-05). Lot 51836, expiring 07/2023, is involved, with approximately 5,208 cartons distributed nationwide.
The recall was initiated because the product failed pharmaceutical specifications during 18-month stability testing. Results showed that the related substance 10-hydroxy buprenorphine N-Oxide exceeded acceptable specification limits, indicating the product may not maintain proper quality throughout its intended shelf life.
Patients currently using this lot should contact their healthcare provider or pharmacist regarding their specific supply. Unused product should be returned to the pharmacy for proper disposal.
The recalled product
- Product
- Buprenorphine Transdermal System, CIII 20 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 60505-7079-05
- Manufacturer
- AVEVA Drug Delivery Systems, Inc.
- Category
- Drug — Opiate transdermal patch
- Hazard
- impurity
- degradation-product
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot#: 51836 Exp: 07/2023
Distribution
Distributed nationwide across the United States.
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