D-0093-2024 Class III Terminated
FDA drug recall D-0093-2024 was initiated by VistaPharm LLC on Oct 26, 2023 and is designated Class III. Reason for recall: Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water. The recall status is terminated (terminated Mar 21, 2025). Affected quantity: 11,633 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 15, 2023
- Initiation Date
- Oct 26, 2023
- Termination Date
- Mar 21, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,633 bottles
Product 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.
Reason for Recall
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Distribution Pattern
Nationwide and Saudi Arabia
Code Information
Lot #: M23400A, M23401A, M23402A, Exp Date. 04/30/2025; M23591A, M23592A, Exp Date. 06/30/2025.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0093-2024
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026