Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455...

FDA Recall #D-1152-2022 — Class II — June 9, 2022

Recall #D-1152-2022 Date: June 9, 2022 Classification: Class II Status: Terminated

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

Reason for Recall

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

Recalling Firm

Mayne Pharma Inc — Greenville, NC

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

1440 cartons

Distribution

Nationwide in the US Market

Code Information

Lot: 41179A Exp. Jan 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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