MENTHOL Recall D-0066-2025
Description: THERACARE Cold Hot Medicated Patch, Menthol 5%, 5 patches per box, Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-954-05, UPC 8 45717 00818 1
MENTHOL Recall D-0066-2025 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0066-2025 |
Event ID | 95595 |
Brand | THERA CARE COLD HOT MEDICATED PATCH |
Generic Name | MENTHOL |
Manufacturer | MENTHOL |
Original Package? | 1 |
Active Substance | MENTHOL |
Drug Route | TOPICAL |
Distribution | Nationwide in the US |
Quantity | 279,936 patches |
Recall Reason | cGMP Deficiencies |
Drug Classification | Class II |
Drug Code Info | 20241204 |
Product NDC | 71101-954 |
Drug UPC | 0845717008181 845717008181 |
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 | L7T10EIP3A |
Drug Application Number | M017 |
Structured Product Labeling (SPL ID) | 20d6f5cc-2c81-74a0-e063-6394a90abfed |
Structured Product Labeling (SPL Set ID) | b1ce129d-06a1-7755-e053-2995a90abd7d |
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