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…
- FDA Drug
- Class II
- terminated
- Published 2022-06-29
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
| Agency | FDA Drug |
|---|---|
| Recall number | D-1152-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-09 |
| Published | 2022-06-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mayne Pharma |
| Distribution | US |
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
| ndc | 51862-453-01 |
|---|---|
| ndc | 51862-453-04 |
| ndc | 51862-454-01 |
| ndc | 51862-454-04 |
| ndc | 51862-455-01 |
| ndc | 51862-455-04 |
| code_info | Lot: 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
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