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Recall Observatory FDA recall evidence

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

October 26, 2023

Class III

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

    reason.no_named_rule · v1.0.0

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

Field note

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