NAPROXEN SODIUM Recall D-0346-2025
Description: Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-179-01
NAPROXEN SODIUM Recall D-0346-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0346-2025 |
| Event ID | 96474 |
| Brand | NAPROXEN SODIUM |
| Generic Name | NAPROXEN SODIUM |
| Manufacturer | NAPROXEN SODIUM |
| Original Package? | 1 |
| Active Substance | NAPROXEN SODIUM |
| Drug Route | ORAL |
| Distribution | U.S. Nationwide |
| Quantity | N/A |
| Recall Reason | CGMP Deviations |
| Drug Classification | Class II |
| Drug Code Info | 20250416 |
| Product NDC | 68462-178 68462-188 68462-189 |
| Product NUI | N0000000160 M0001335 N0000175722 |
| Drug UPC | 0368462179017 0368462178010 0368462189016 |
| Pharma Class (EPC) | Nonsteroidal Anti-inflammatory Drug [EPC] |
| Pharma Class (CS) | Anti-Inflammatory Agents, Non-Steroidal [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 | 9TN87S3A3C 57Y76R9ATQ |
| Drug Application Number | ANDA078314 |
| Structured Product Labeling (SPL ID) | b7cce793-fe49-4fe0-8848-fc89f7ea3832 |
| Structured Product Labeling (SPL Set ID) | 6c5bb008-e66f-4ef0-bf84-aca7eb5983e9 |
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