D-342-2014 Class II Terminated
FDA drug recall D-342-2014 was initiated by VistaPharm, Inc. on Oct 15, 2013 and is designated Class II. 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. The recall status is terminated (terminated Sep 28, 2016). Affected quantity: 27,788 cases.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 18, 2013
- Initiation Date
- Oct 15, 2013
- Termination Date
- Sep 28, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27,788 cases
Product Description
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
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 Pattern
Nationwide and Puerto Rico
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-342-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026