Recall: D-1152-2022

Class II - Potentially Harmful

Class IIClassification

2022-06-09Initiated

TerminatedStatus

Mayne Pharma IncFirm

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 Greenville, NC 27834

Reason

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

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.