October 2023 FDA Recall Mycophenolate Mofetil by Vistapharm Llc
D-0093-2024 - Defective Container
This Class III drug recall was voluntarily initiated by Vistapharm Llc on October 26, 2023 for the product Mycophenolate Mofetil. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0093-2024
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
10-26-2023
11-15-2023
11,633 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
VistaPharm LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Saudi Arabia
03-21-2025
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
