D-1658-2012 Class II Terminated
FDA drug recall D-1658-2012 was initiated by VistaPharm, Inc. on Apr 6, 2011 and is designated Class II. Reason for recall: Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The… The recall status is terminated (terminated Nov 23, 2012).
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 29, 2012
- Initiation Date
- Apr 6, 2011
- Termination Date
- Nov 23, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC 66689-035-50
Reason for Recall
Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume
Distribution Pattern
Nationwide
Code Information
Lot 202800, NDC 66689-035-50
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1658-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026