RecallRadar

FDA Drug recall D-1152-2022

Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufactured for: Mayne Phar…

On 2022-06-29 the FDA classified a Class II recall of Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufactured for: Mayne Phar… by Mayne Pharma, citing defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1152-2022
ClassificationClass II
Statusterminated
Initiated2022-06-09
Published2022-06-29
Last updated2026-09-13 11:52 UTC
CompanyMayne Pharma
DistributionUS

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.

Identifiers

ndc51862-453-01
ndc51862-453-04
ndc51862-454-01
ndc51862-454-04
ndc51862-455-01
ndc51862-455-04
code_infoLot: 41179A Exp. Jan 2023

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1152-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.