Drug product
Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50
D-1440-2012
Product summary
- Firm
- VistaPharm, Inc.
- Event
- Event 62421
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27,221 unit dose cups
- Official record key
drug-enforcement:D-1440-2012
Official wording
Reason: 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.
Code information: Lot #'s 210900, 214000, 220100, 224800, 228700, 232800
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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.