RANOLAZINE Recall D-0335-2025
Description: Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-320-60
RANOLAZINE Recall D-0335-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0335-2025 |
| Event ID | 96474 |
| Brand | RANOLAZINE |
| Generic Name | RANOLAZINE |
| Manufacturer | RANOLAZINE |
| Original Package? | 1 |
| Active Substance | RANOLAZINE |
| Drug Route | ORAL |
| Distribution | U.S. Nationwide |
| Quantity | N/A |
| Recall Reason | CGMP Deviations |
| Drug Classification | Class II |
| Drug Code Info | 20250416 |
| Product NDC | 68462-319 68462-320 |
| Product NUI | N0000175427 N0000190114 N0000185503 |
| Drug UPC | 0368462320600 0368462319604 |
| Pharma Class (EPC) | Anti-anginal [EPC] |
| 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 | A6IEZ5M406 |
| Drug Application Number | ANDA211082 |
| Structured Product Labeling (SPL ID) | 8872581f-53be-4bde-8d22-c6960f11e9d6 |
| Structured Product Labeling (SPL Set ID) | 0cf58732-c242-49b0-8e3f-248778b4458d |
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