Enforcement Report - Week of September 11, 2013
Product Detail
| Product Description | Pentosan Polysulfate Sodium (K9) 150 mg/ml aqueous solution for injection, for Veterinary Use only 10 mL Sterile amber vials Refrigerated Storage required. Item Code PENTOS-INJ007VC This preparation is dispensed with a prescription label, so each vial would be individually labeled with specific information containing not only the drug name, strength, etc. but also the patient name, prescriber name, and directions for use. |
|---|---|
| Recall Number | V-312-2013 |
| Classification | Class II |
| Code Info | Lot number 20130618@409, Beyond Use Date 12/15/2013 |
| Product Distributed Qty | 34 units |
| Reason For Recall | Routine endotoxin testing of this batch indicated that the finished injection solution contained a concentration of endotoxins exceeding established endotoxin concentration limits. A second sample tested from this same lot confirmed the higher than expected endotoxin concentration. |
Event Detail
| Event Id | 66042 |
|---|---|
| Product Type | Veterinary |
| Status | Ongoing |
| Recalling Firm | Wedgewood Village Pharmacy, Inc. |
| City | Swedesboro |
| State | NJ |
| Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2013-06-28 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Distribution Pattern | Nationwide |
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