MYCOPHENOLATE MOFETIL Recall D-0093-2024
Description: Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08.
MYCOPHENOLATE MOFETIL Recall D-0093-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0093-2024 |
| Event ID | 93322 |
| Brand | MYCOPHENOLATE MOFETIL |
| Generic Name | MYCOPHENOLATE MOFETIL |
| Manufacturer | MYCOPHENOLATE MOFETIL |
| Original Package? | 1 |
| Active Substance | MYCOPHENOLATE MOFETIL |
| Drug Route | ORAL |
| Distribution | Nationwide and Saudi Arabia |
| Quantity | 11,633 bottles |
| Recall Reason | Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water. |
| Drug Classification | Class III |
| Drug Code Info | 20231115 |
| Product NDC | 66689-307 |
| Recall Initiation Date | 20231026 |
| Report Date | 20231115 |
| Classification Date | 20231108 |
| Address | 7265 Ulmerton Rd Largo, FL 33771-4809 United States |
| Recalling Firm | VistaPharm LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 9242ECW6R0 |
| Drug Application Number | ANDA210370 |
| Structured Product Labeling (SPL ID) | 5cd07ba1-653b-48cc-9761-337112ec05e9 |
| Structured Product Labeling (SPL Set ID) | 175d8b87-e06a-4c9e-b3de-378114b52274 |
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