BUDESONIDE Recall D-0275-2024
Description: Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2510-30
BUDESONIDE Recall D-0275-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0275-2024 |
| Event ID | 93740 |
| Brand | BUDESONIDE |
| Generic Name | BUDESONIDE |
| Manufacturer | BUDESONIDE |
| Original Package? | 1 |
| Active Substance | BUDESONIDE |
| Drug Route | ORAL |
| Distribution | Nationwide |
| Quantity | 10,672 30-count bottles |
| Recall Reason | Failed Dissolution Specifications |
| Drug Classification | Class II |
| Drug Code Info | 20240207 |
| Product NDC | 0591-2510 |
| Product NUI | N0000175576 N0000175450 |
| Pharma Class (EPC) | Corticosteroid [EPC] |
| Recall Initiation Date | 20240108 |
| Report Date | 20240207 |
| Classification Date | 20240126 |
| Address | 400 Interpace Pkwy Bldg A Parsippany, NJ 07054-1120 United States |
| Recalling Firm | Teva Pharmaceuticals USA, Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | Q3OKS62Q6X |
| Drug Application Number | ANDA205457 |
| Structured Product Labeling (SPL ID) | 29146990-42bc-43d6-8b61-717df1c7e054 |
| Structured Product Labeling (SPL Set ID) | 41d4fd39-81ee-41be-b34d-efb12b3a359d |
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