HYDRALAZINE HYDROCHLORIDE Recall D-0045-2025
Description: Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61.
HYDRALAZINE HYDROCHLORIDE Recall D-0045-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0045-2025 |
| Event ID | 95700 |
| Brand | HYDRALAZINE HYDROCHLORIDE |
| Generic Name | HYDRALAZINE HYDROCHLORIDE |
| Manufacturer | HYDRALAZINE HYDROCHLORIDE |
| Active Substance | HYDRALAZINE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide in the US. |
| Quantity | 25814 tablets |
| Recall Reason | Failed impurities/degradation specifications during routine stability testing for impurities. |
| Drug Classification | Class III |
| Drug Code Info | 20241120 |
| Product NDC | 0904-6441 0904-6440 0904-6442 |
| Recall Initiation Date | 20241105 |
| Report Date | 20241120 |
| Classification Date | 20241114 |
| Address | 341 Mason RdN/A La Vergne, TN 37086-3606 United States |
| Recalling Firm | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories |
| Initial Notification | Letter |
| Unique Ingredient Identifier | FD171B778Y |
| Drug Application Number | ANDA086242 |
| Structured Product Labeling (SPL ID) | b3e6cf2f-1dd6-4d0a-b687-423da164b209 |
| Structured Product Labeling (SPL Set ID) | 7dc7c11b-ac51-4db3-ac6a-708c676a8859 |
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