D-1440-2012 Class II Terminated
FDA drug recall D-1440-2012 was initiated by VistaPharm, Inc. on Sep 30, 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 Dec 12, 2013). Affected quantity: 27,221 unit dose cups.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 8, 2012
- Initiation Date
- Sep 30, 2011
- Termination Date
- Dec 12, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27,221 unit dose cups
Product Description
Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50
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 #'s 210900, 214000, 220100, 224800, 228700, 232800
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1440-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026