Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufac
Summary
The FDA issued a Class II for Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per C by Mayne Pharma Inc. Reason: Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint..
Details
Source
Drug Recall
External ID
D-1152-2022
Action Date
2022-06-29
Status
Terminated
Category
drug
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
Lot/Code Info: Lot: 41179A Exp. Jan 2023
Quantity Affected: 1440 cartons
Reason for Recall
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Distribution
Nationwide in the US Market
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-09
Company
Greenville, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 45 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Mayne Pharma Inc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mayne Pharma Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mayne Pharma Inc have FDA actions?
Mayne Pharma Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1152-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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