FDA-Drug2013-12-18Class II
Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50
VistaPharm, Inc.
Hazard
Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.
Sold states
Nationwide and Puerto Rico
Affected count
27,788 cases
Manufactured in
7265 Ulmerton Rd, Largo, FL, United States
Products
Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-342-2014Don't want to check this manually?
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