Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08.

FDA recall notice · announced November 15, 2023 · Vistapharm

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

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.

Reason for recall

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

Notes

Distribution: Nationwide and Saudi Arabia
Lot/code information: Lot #: M23400A, M23401A, M23402A, Exp Date. 04/30/2025; M23591A, M23592A, Exp Date. 06/30/2025.
Quantity: 11,633 bottles
Status: Terminated
Products in this recall event:
- Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08. (D-0093-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.