Class II Recall

Mayne Pharma Inc

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.
Classification
Class II
Status
Terminated
Lot
Lot: 41179A Exp. Jan 2023
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.