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Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 dispos...

FDA Recall #D-0465-2023 — Class III — February 15, 2023

Recall #D-0465-2023 Date: February 15, 2023 Classification: Class III Status: Terminated

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.

Recalling Firm

AVEVA Drug Delivery Systems, Inc. — Miramar, FL

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

11,520 cartons

Distribution

Nationwide

Code Information

Lot#: 51835 Exp: 06/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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