FDA recall D-0093-2024

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.

Reason for recall

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

Distribution

Nationwide and Saudi Arabia

Key facts

Status

Terminated

Initiation date

2023-10-26

Report date

2023-11-15

Termination date

2025-03-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Largo, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0093-2024