Mayne Pharma Inc: Drug Recall

Recall #D-1152-2022 · 06/09/2022

Class II: Risk

Recall Details

Recall Number
D-1152-2022
Classification
Class II
Product Type
Drug
Recalling Firm
Mayne Pharma Inc
Status
Terminated
Date Initiated
06/09/2022
Location
Greenville, NC, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1440 cartons

Reason for Recall

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

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

Distribution Pattern

Nationwide in the US Market

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.