FDAClass IIJune 29, 2022

Clonidine Transdermal System recall

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…

Why was Clonidine Transdermal System recalled?

Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 41179A Exp. Jan 2023

Product
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…
Recalling firm
Mayne Pharma Inc
Quantity
1440 cartons
Distribution
Nationwide in the US Market
Recall date
June 29, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls