AZACITIDINE Recall D-1334-2022
Description: Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
AZACITIDINE Recall D-1334-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1334-2022 |
| Event ID | 90594 |
| Brand | AZACITIDINE |
| Generic Name | AZACITIDINE |
| Manufacturer | AZACITIDINE |
| Original Package? | 1 |
| Active Substance | AZACITIDINE |
| Drug Route | INTRAVENOUS |
| Distribution | Distributed in Ohio |
| Quantity | 4162 cartons |
| Recall Reason | Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification. |
| Drug Classification | Class III |
| Drug Code Info | 20220817 |
| Product NDC | 68001-313 |
| Product NUI | N0000000233 N0000175595 |
| Drug UPC | 0368001313568 |
| Pharma Class (EPC) | Nucleoside Metabolic Inhibitor [EPC] |
| Recall Initiation Date | 20220722 |
| Report Date | 20220817 |
| Classification Date | 20220811 |
| Address | 400 Interpace Pkwy Bldg A Parsippany, NJ 07054-1120 United States |
| Recalling Firm | Teva Pharmaceuticals USA Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | M801H13NRU |
| Drug Application Number | NDA208216 |
| Structured Product Labeling (SPL ID) | e56bd41d-d454-2fd3-e053-2a95a90aa361 |
| Structured Product Labeling (SPL Set ID) | 5f0f9ee3-a5b1-4a25-a34c-7f38c8433f4a |
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