Multi event Drug Recall Enforcement Report Class II voluntary initiated by Glenmark Pharmaceuticals Inc., USA, originally initiated on 12-11-2024 for the product chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01 The product was recalled due to cgmp deviations: n-nitroso-desmethyl chlorpromazine impurity (nndci) were found to be failing per current fda recommended limit.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0159-2025 | 12-11-2024 | 01-01-2025 | Class II | 3,888 | chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01 | CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit. | Ongoing |
| D-0160-2025 | 12-11-2024 | 01-01-2025 | Class II | | chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01 | CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit. | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 68462-861 | Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-862 | Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-863 | Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-864 | Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-865 | Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | Tablet, Film Coated | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
