Enforcement Report - Week of August 29, 2012
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Product Detail
| Product Description | 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 |
|---|---|
| Recall Number | D-1658-2012 |
| Classification | Class II |
| Code Info | Lot 202800, NDC 66689-035-50 |
| Product Distributed Qty | |
| 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 | 62893 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | VistaPharm, Inc. |
| City | Largo |
| State | FL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-04-06 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
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