SAXAGLIPTIN HYDROCHLORIDE Recall D-0345-2025
Description: Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
SAXAGLIPTIN HYDROCHLORIDE Recall D-0345-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0345-2025 |
| Event ID | 96474 |
| Brand | SAXAGLIPTIN |
| Generic Name | SAXAGLIPTIN |
| Manufacturer | SAXAGLIPTIN |
| Original Package? | 1 |
| Active Substance | SAXAGLIPTIN HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | U.S. Nationwide |
| Quantity | N/A |
| Recall Reason | CGMP Deviations |
| Drug Classification | Class II |
| Drug Code Info | 20250416 |
| Product NDC | 68462-726 68462-727 |
| Drug UPC | 0368462726907 |
| 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 | Z8J84YIX6L |
| Drug Application Number | ANDA205994 |
| Structured Product Labeling (SPL ID) | e286ffd4-c598-47fb-af06-2e15f7e6f99f |
| Structured Product Labeling (SPL Set ID) | e286ffd4-c598-47fb-af06-2e15f7e6f99f |
| Similar To |