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

Recall Number: D-1152-2022

Firm: Mayne Pharma Inc

Classification: Class II

Status: Terminated

Report Date: 20220629

Initiation Date: 20220609

Termination Date: 20230823

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

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