HYDRALAZINE HYDROCHLORIDE Recall D-0039-2024
Description: HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 68084-447-01; Individual Dose NDC: 68084-447-11
HYDRALAZINE HYDROCHLORIDE Recall D-0039-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0039-2024 |
| Event ID | 93089 |
| Brand | HYDRALAZINE HYDROCHLORIDE |
| Generic Name | HYDRALAZINE HYDROCHLORIDE |
| Manufacturer | HYDRALAZINE HYDROCHLORIDE |
| Active Substance | HYDRALAZINE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 3,344 cartons |
| Recall Reason | Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point. |
| Drug Classification | Class III |
| Drug Code Info | 20231011 |
| Product NDC | 68084-447 |
| Recall Initiation Date | 20230901 |
| Report Date | 20231011 |
| Classification Date | 20231005 |
| Address | 2550 John Glenn Ave Ste A Columbus, OH 43217-1188 United States |
| Recalling Firm | Amerisource Health Services LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | FD171B778Y |
| Drug Application Number | ANDA086242 |
| Structured Product Labeling (SPL ID) | f2f6a6a4-9f02-25f4-e053-2995a90adfc3 |
| Structured Product Labeling (SPL Set ID) | 53908945-540f-4d34-8f0a-b4a87676634e |
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