Clonidine Patch, Extended Release
FDA Recall NDC 51862-455
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 Clonidine (NDC 51862-455). A significant event, classified as Class II, was initiated on Jun 09, 2022 by Mayne Pharma Inc.. The reported reason for this action was: "Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint."
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
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Jun 09, 2022
Jun 29, 2022
1440 cartons
Recall Profile & Regulatory Data
Event ID
90406
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mayne Pharma Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US Market
Termination Date
Aug 23, 2023
Product Description
Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufactured for: Mayne Pharma Greenville, NC 27834
Batch or Lot Expiration Information
Lot# Lot: 41179A Exp. Jan 2023
Affected Packages Involved in this Recall
51862-453-01Product
51862-453-04Product
51862-454-01Product
51862-454-04Product
51862-455-01Product
51862-455-04Product
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.
