FDA-Drug2012-08-29Class II
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
VistaPharm, Inc.
Hazard
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
Sold states
Nationwide
Affected count
N/A
Manufactured in
7265 Ulmerton Rd, N/A, Largo, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1658-2012Don't want to check this manually?
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