Clonidine Transdermal System — Class II drug recall D-1152-2022
Terminated recall by Mayne Pharma Inc, reported 2022-06-29, distributed nationwide. Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT sta
| Recall number | D-1152-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mayne Pharma Inc, Greenville, NC, United States |
| Recall initiated | 2022-06-09 |
| Classified | 2022-06-21 |
| Reported by FDA | 2022-06-29 |
| Terminated | 2023-08-23 |
| Distributed | Nationwide (US) |
| Quantity | 1,440 cartons |
| Reason classes | specification failure |
| NDC | 51862-0453, 51862-0453-01, 51862-0453-04, 51862-0454, 51862-0454-01, 51862-0454-04, 51862-0455, 51862-0455-01, 51862-0455-04 |
| Lot numbers | 41179A |
| Expiration dates | 2023-01-20 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1152-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.