Drug 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.
D-0093-2024
Product summary
- Firm
- VistaPharm LLC
- Event
- Event 93322
- Status
- Terminated
- Classification
- Class III
- Quantity
- 11,633 bottles
- Official record key
drug-enforcement:D-0093-2024
Official wording
Reason: Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Code information: Lot #: M23400A, M23401A, M23402A, Exp Date. 04/30/2025; M23591A, M23592A, Exp Date. 06/30/2025.
Distribution pattern: Nationwide and Saudi Arabia
Derived failure modes
-
Unknown
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.