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Recall Observatory FDA recall evidence

Drug product

Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50

D-342-2014

October 15, 2013

Class II

Product summary

Firm
VistaPharm, Inc.
Event
Event 66945
Status
Terminated
Classification
Class II
Quantity
27,788 cases
Official record key
drug-enforcement:D-342-2014

Official wording

Reason: Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.

Code information: Lots #'s: 268200, Exp 06/14; 274600, Exp 08/14; 279500, Exp 09/14; 290700, Exp 12/14; 296700, Exp 02/15; 305100, Exp 06/15

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification