# FDA recall D-1152-2022

> **Mayne Pharma Inc** · Class II · drug recall initiated 2022-06-09.

## 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

- **Recall number:** D-1152-2022
- **Recalling firm:** Mayne Pharma Inc
- **Classification:** Class II
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-1152-2022. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-1152-2022. Source: US FDA. Licensed CC0.

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