Class II
Terminated
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
- Company
- Vistapharm, Inc.
- Recall Initiated
- October 15, 2013
- Posted
- December 18, 2013
- Recall Number
- D-342-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 27,788 cases
- Firm Location
- Largo, FL, United States
Reason for Recall
Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
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
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