FDA recall D-1152-2022

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 for recall

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

Key facts

Status

Terminated

Initiation date

2022-06-09

Report date

2022-06-29

Termination date

2023-08-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Greenville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1152-2022