CETIRIZINE HYDROCHLORIDE Recall D-0348-2025
Description: Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35
CETIRIZINE HYDROCHLORIDE Recall D-0348-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0348-2025 |
| Event ID | 96474 |
| Brand | CETIRIZINE HCL |
| Generic Name | CETIRIZINE |
| Manufacturer | CETIRIZINE |
| Original Package? | 1 |
| Active Substance | CETIRIZINE 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 | 72657-128 72657-129 72657-130 |
| Drug UPC | 0372657129350 0372657128353 |
| 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 | 64O047KTOA |
| Drug Application Number | ANDA078427 |
| Structured Product Labeling (SPL ID) | fd1924df-96c1-4429-944d-bd09a7dd2a6b |
| Structured Product Labeling (SPL Set ID) | 04b08c52-5390-4cdb-a9e7-fca81fffdc73 |
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