Medications & Supplements/Prescription Drugs

Apotex Buprenorphine Transdermal Systems Recalled for Impurity Specifications

Agency Publication Date: March 14, 2023

Summary

AVEVA Drug Delivery Systems, Inc. is voluntarily recalling approximately 16,728 cartons of Apotex brand Buprenorphine Transdermal Systems (medicated pain patches) in 10 mcg/hour and 20 mcg/hour strengths. Routine stability testing found that the patches exceeded the allowable limit for a specific impurity called 10-hydroxy buprenorphine N-Oxide. No incidents or injuries have been reported in connection with this issue.

Risk

The patches contain levels of a degradation byproduct that are outside of approved safety specifications, which could potentially impact the purity or effectiveness of the medication.

What You Should Do

This recall affects Apotex brand Buprenorphine Transdermal Systems (CIII) in 10 mcg/hour and 20 mcg/hour strengths, sold in cartons containing four transdermal systems and four disposal units.
Identify if your product is affected by checking the NDC and lot number on the outer packaging. Affected 10 mcg/hour patches have NDC 60505-7077-05 and Lot 51835 (Exp 06/2023). Affected 20 mcg/hour patches have NDC 60505-7079-05 and Lot 51836 (Exp 07/2023).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Buprenorphine Transdermal System (10 mcg/hour)by Apotex

Variants: 10 mcg/hour, 4 Transdermal Systems per carton

Lot Numbers:

51835 (Exp: 06/2023)

NDC:

60505-7077-05

Manufactured for Apotex Corp.

Product: Buprenorphine Transdermal System (20 mcg/hour)by Apotex

Variants: 20 mcg/hour, 4 Transdermal Systems per carton

Lot Numbers:

51836 (Exp: 07/2023)

NDC:

60505-7079-05

Manufactured for Apotex Corp.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91712

Status: Resolved

Manufacturer: AVEVA Drug Delivery Systems, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 2 products (11,520 cartons; 5,208 cartons)

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Apotex brand Buprenorphine Transdermal Systems (CIII) in 10 mcg/hour and 20 mcg/hour strengths, sold in cartons containing four transdermal systems and four disposal units.

Identify if your product is affected by checking the NDC and lot number on the outer packaging. Affected 10 mcg/hour patches have NDC 60505-7077-05 and Lot 51835 (Exp 06/2023). Affected 20 mcg/hour patches have NDC 60505-7079-05 and Lot 51836 (Exp 07/2023).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Buprenorphine Transdermal System (10 mcg/hour)by Apotex

Variants: 10 mcg/hour, 4 Transdermal Systems per carton

Lot Numbers:

51835 (Exp: 06/2023)

NDC:

60505-7077-05

Manufactured for Apotex Corp.

Product: Buprenorphine Transdermal System (20 mcg/hour)by Apotex

Variants: 20 mcg/hour, 4 Transdermal Systems per carton

Lot Numbers:

51836 (Exp: 07/2023)

NDC:

60505-7079-05

Manufactured for Apotex Corp.