Mayne Pharma Inc recalls Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufact…

Recall date

June 9, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1152-2022

FDA classification

Class II

Brand / firm

Mayne Pharma Inc

Sold / distributed

Nationwide in the US Market

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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