CAMPHOR (SYNTHETIC) Recall D-0072-2025
Description: PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6 patches per box, Distributed by: Pharmadel LLC, Georgetown, DE 19947 NDC 55758-039-01, UPC 8 59424 00433 6
CAMPHOR (SYNTHETIC) Recall D-0072-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0072-2025 |
| Event ID | 95595 |
| Brand | PARCHE LEON |
| Generic Name | CAPSAICIN, CAMPHOR, MENTHOL |
| Manufacturer | CAPSAICIN, CAMPHOR, MENTHOL |
| Original Package? | 1 |
| Active Substance | CAMPHOR (SYNTHETIC) CAPSAICIN |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the US |
| Quantity | 28,864 patches |
| Recall Reason | cGMP Deficiencies |
| Drug Classification | Class II |
| Drug Code Info | 20241204 |
| Product NDC | 55758-039 |
| Drug UPC | 859424004336 |
| Recall Initiation Date | 20241024 |
| Report Date | 20241204 |
| Classification Date | 20241122 |
| Address | B16, Sector 4, Bawana Industrial Area New Delhi, N/A India |
| Recalling Firm | Unexo Life Sciences Private Limited |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 5TJD82A1ET S07O44R1ZM |
| Drug Application Number | part348 |
| Structured Product Labeling (SPL ID) | f6f741c5-87eb-63e4-e053-6294a90ad783 |
| Structured Product Labeling (SPL Set ID) | a8f266fa-6e43-559e-e053-2995a90a2c75 |
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