Class II
Terminated
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
- Company
- Vistapharm, Inc.
- Recall Initiated
- April 6, 2011
- Posted
- August 29, 2012
- Recall Number
- D-1658-2012
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Largo, FL, United States
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
Nationwide
Lot / Code Info
Lot 202800, NDC 66689-035-50
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