Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: Vis...
FDA Recall #D-0093-2024 — Class III — October 26, 2023
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.
Recalling Firm
VistaPharm LLC — Largo, FL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
11,633 bottles
Distribution
Nationwide and Saudi Arabia
Code Information
Lot #: M23400A, M23401A, M23402A, Exp Date. 04/30/2025; M23591A, M23592A, Exp Date. 06/30/2025.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated