FENOFIBRATE Recall D-0314-2025
Description: Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-580-01
FENOFIBRATE Recall D-0314-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0314-2025 |
| Event ID | 96474 |
| Brand | FENOFIBRATE |
| Generic Name | FENOFIBRATE |
| Manufacturer | FENOFIBRATE |
| Original Package? | 1 |
| Active Substance | FENOFIBRATE |
| Drug Route | ORAL |
| Distribution | U.S. Nationwide |
| Quantity | N/A |
| Recall Reason | CGMP Deviations |
| Drug Classification | Class II |
| Drug Code Info | 20250416 |
| Product NDC | 68462-580 68462-581 68462-582 |
| Product NUI | N0000175596 N0000175375 M0199111 |
| Drug UPC | 0368462581018 0368462580011 0368462582015 |
| Pharma Class (EPC) | Peroxisome Proliferator Receptor alpha Agonist [EPC] |
| Pharma Class (CS) | PPAR alpha [CS] |
| Recall Initiation Date | 20250313 |
| Report Date | 20250416 |
| Classification Date | 20250408 |
| Address | 750 Corporate DrN/A Mahwah, NJ 07430-2009 United States |
| Recalling Firm | Glenmark Pharmaceuticals Inc., USA |
| Initial Notification | Letter |
| Unique Ingredient Identifier | U202363UOS |
| Drug Application Number | ANDA205566 |
| Structured Product Labeling (SPL ID) | 65523b48-95b4-4491-94cc-5c3c79ac41a8 |
| Structured Product Labeling (SPL Set ID) | e7204052-02cf-4b38-835b-d8754c74b2cd |
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