Mycophenolate Mofetil Powder, For Suspension
FDA Recall NDC 66689-307
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Mycophenolate Mofetil (NDC 66689-307). A significant event, classified as Class III, was initiated on Oct 26, 2023 by Vistapharm, Llc. The reported reason for this action was: "Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Oct 26, 2023
Nov 15, 2023
11,633 bottles
Recall Profile & Regulatory Data
Event ID
93322
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
VistaPharm LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Saudi Arabia
Termination Date
Mar 21, 2025
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.
Batch or Lot Expiration Information
Lot# : M23400A, M23401A, M23402A, Exp Date. 04/30/2025; M23591A, M23592A, Exp Date. 06/30/2025.
Affected Packages Involved in this Recall
66689-307-08Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
