VistaPharm LLC: Drug Recall

Recall #D-0093-2024 · 10/26/2023

Class III: Low Risk

Recall Details

Recall Number: D-0093-2024
Classification: Class III
Product Type: Drug
Recalling Firm: VistaPharm LLC
Status: Terminated
Date Initiated: 10/26/2023
Location: Largo, FL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 11,633 bottles

Reason for Recall

Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.

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.

Distribution Pattern

Nationwide and Saudi Arabia

Other Recalls by VistaPharm LLC

Class I: Dangerous 10/18/2023

Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Class III: Low Risk 10/17/2023

Failed Excipient Specifications: high content of ethylene glycol (EG)
Class II: Risk 08/30/2023

Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results

View all recalls by VistaPharm LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.