FDA recall D-342-2014

Product

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

Reason for recall

Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2013-10-15

Report date

2013-12-18

Termination date

2016-09-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Largo, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-342-2014