CHLORPROMAZINE HYDROCHLORIDE Recall D-0361-2025
Description: chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1129-1
CHLORPROMAZINE HYDROCHLORIDE Recall D-0361-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0361-2025 |
| Event ID | 96626 |
| Brand | CHLORPROMAZINE HYDROCHLORIDE |
| Generic Name | CHLORPROMAZINE HYDROCHLORIDE |
| Manufacturer | CHLORPROMAZINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | CHLORPROMAZINE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide within U.S - MS, AL, TN, VT, OH, ND, MN, WI, SC, AR, FL, IN, LA, NJ, AZ, TX, KY and PA |
| Quantity | 3144 bottles, pack size: 100's Count |
| Recall Reason | CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit |
| Drug Classification | Class II |
| Drug Code Info | 20250416 |
| Product NDC | 70710-1129 70710-1130 70710-1131 |
| Drug UPC | 0370710112912 0370710113216 0370710113018 |
| Recall Initiation Date | 20250403 |
| Report Date | 20250416 |
| Classification Date | 20250410 |
| Address | 73 Route 31 NN/A Pennington, NJ 08534-3601 United States |
| Recalling Firm | Zydus Pharmaceuticals (USA) Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 9WP59609J6 |
| Drug Application Number | ANDA213368 |
| Structured Product Labeling (SPL ID) | 8a5df7d8-ad17-44d7-9c56-44fa2aaa0852 |
| Structured Product Labeling (SPL Set ID) | fc2bd95d-a7bc-4ab5-bffa-f5059cb8eb63 |
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