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
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.