FDAFDA · Food and drugs·Recall number D-342-2014
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
Published December 18, 2013 · Recall initiated: October 15, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- VistaPharm, Inc.
- Distributor
- Nationwide and Puerto Rico
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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