CLONIDINE Recall D-1152-2022
Description: 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
CLONIDINE Recall D-1152-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1152-2022 |
| Event ID | 90406 |
| Brand | CLONIDINE |
| Generic Name | CLONIDINE |
| Manufacturer | CLONIDINE |
| Original Package? | 1 |
| Active Substance | CLONIDINE |
| Drug Route | TRANSDERMAL |
| Distribution | Nationwide in the US Market |
| Quantity | 1440 cartons |
| Recall Reason | Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint. |
| Drug Classification | Class II |
| Drug Code Info | 20220629 |
| Product NDC | 51862-453 51862-454 51862-455 |
| Product NUI | N0000009918 N0000175554 |
| Pharma Class (EPC) | Central alpha-2 Adrenergic Agonist [EPC] |
| Recall Initiation Date | 20220609 |
| Report Date | 20220629 |
| Classification Date | 20220621 |
| Address | 1240 Sugg Pkwy Greenville, NC 27834-9006 United States |
| Recalling Firm | Mayne Pharma Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | MN3L5RMN02 |
| Drug Application Number | ANDA079090 |
| Structured Product Labeling (SPL ID) | d876b634-0405-4ace-b85d-27191bb0b1fc |
| Structured Product Labeling (SPL Set ID) | c41eb913-5e47-46c4-9d96-9a67f8380919 |
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