Buprenorphine Patch, Extended Release
FDA Recall NDC 0093-3239
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Buprenorphine (NDC 0093-3239). A significant event, classified as Class II, was initiated on Sep 04, 2020 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "Failed Stability Specifications: Below specification result for buprenorphine release rate."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Stability Specifications: Below specification result for buprenorphine release rate.
Sep 04, 2020
Oct 07, 2020
32,543 cartons
Recall Profile & Regulatory Data
Event ID
86379
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S. and PR
Termination Date
Aug 26, 2021
Product Description
Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by: 3M Drug Delivery Systems, 19901 Nordhoff street, Northridge, CA 91324 USA, Manufactured for: Teva Pharmaceuticals USA Inc., North Wales, PA 19454, carton NDC: 0093-3656-40, patch NDC: 0093-3656-21.
Batch or Lot Expiration Information
Lot# 190017, exp. 02/2021; 190161, exp. 08/2021
Affected Packages Involved in this Recall
0093-3656-40Product
0093-3239-40Product
0093-3657-40Product
0093-3658-40Product
0093-3659-40Product
0093-3656-21Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
