Enforcement Report - Week of August 8, 2012
-
Back to Previous Page
Product Detail
| Product Description | Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, 50 unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50 |
|---|---|
| Recall Number | D-1440-2012 |
| Classification | Class II |
| Code Info | Lot #'s 210900, 214000, 220100, 224800, 228700, 232800 |
| Product Distributed Qty | 27,221 unit dose cups |
| 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. |
Event Detail
| Event Id | 62421 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | VistaPharm, Inc. |
| City | Largo |
| State | FL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-09-30 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
-
