Reported Dec 18, 2013 · Terminated
Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by:…
VistaPharm, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: VistaPharm, Inc. · 7265 Ulmerton Rd · Largo, FL · 33771-4809
Is this the product you have?
- Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only
- Manufactured byVistaPharm Inc, Largo, FL 33771, NDC 66689-036-50
- Lot codes and dates
Lots #'s: 268200Exp 06/14274600Exp 08/14279500Exp 09/14290700Exp 12/14296700Exp 02/15305100Exp 06/15
- Amount recalled
- 27,788 cases
Where it was sold
- Nationwide
- PR
Why it was recalled
Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.
This product could cause temporary or reversible health problems — stop using it.
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