CHLORPROMAZINE HYDROCHLORIDE Recall D-0159-2025
Description: chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01
CHLORPROMAZINE HYDROCHLORIDE Recall D-0159-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0159-2025 |
| Event ID | 95936 |
| Brand | CHLORPROMAZINE HYDROCHLORIDE |
| Generic Name | CHLORPROMAZINE HYDROCHLORIDE |
| Manufacturer | CHLORPROMAZINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | CHLORPROMAZINE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | USA Nationwide |
| Quantity | 3,888 |
| Recall Reason | CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit. |
| Drug Classification | Class II |
| Drug Code Info | 20250101 |
| Product NDC | 68462-861 68462-862 68462-863 |
| Drug UPC | 0368462862018 0368462864012 0368462863015 |
| Recall Initiation Date | 20241211 |
| Report Date | 20250101 |
| Classification Date | 20241223 |
| Address | 750 Corporate Dr Mahwah, NJ 07430-2009 United States |
| Recalling Firm | Glenmark Pharmaceuticals Inc., USA |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 9WP59609J6 |
| Drug Application Number | ANDA212144 |
| Structured Product Labeling (SPL ID) | 440a4208-83cc-4ffa-952c-d9c0745c342a |
| Structured Product Labeling (SPL Set ID) | a6065ac5-a111-449b-b51b-8bc2907d1ddb |
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