PAZOPANIB HYDROCHLORIDE Recall D-0149-2024
Description: Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried Barbera, S.L., Barbera del Valles, Spain, Distributed by: Novartis Pharmaceuticals Corp., East Hanover, N.J. 07936, NDC 0078-1077-66
PAZOPANIB HYDROCHLORIDE Recall D-0149-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0149-2024 |
| Event ID | 93429 |
| Brand | VOTRIENT |
| Generic Name | PAZOPANIB HYDROCHLORIDE |
| Manufacturer | PAZOPANIB HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | PAZOPANIB HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide |
| Quantity | 2016 |
| Recall Reason | Failed Dissolution Specifications |
| Drug Classification | Class III |
| Drug Code Info | 20231220 |
| Product NDC | 0078-0670 0078-1077 |
| Recall Initiation Date | 20231120 |
| Report Date | 20231220 |
| Classification Date | 20231213 |
| Address | Ronda De St Maria 158 Barbera Del Valles, Spain |
| Recalling Firm | Siegfried Barbera, SL |
| Unique Ingredient Identifier | 33Y9ANM545 |
| Drug Application Number | NDA022465 |
| Structured Product Labeling (SPL ID) | 929749e3-ee9b-4550-b583-c78290919caf |
| Structured Product Labeling (SPL Set ID) | eeaaaf38-fb86-4d9f-a19d-0f61daac2fd7 |
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