The Recall Desk
ModerateFDA (Drugs)·D-0466-2023·Announced 2023-03-22

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
Affected units
5,208

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.

Part of a larger recall action

This product is one of 2 recalled by AVEVA Drug Delivery Systems, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · AVEVA Drug Delivery Systems, Inc.

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Same hazard · impurity

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