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U.S. Department of Health and Human Services

Enforcement Report - Week of September 11, 2013

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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