Thursday, September 12, 2013

URGENT! FDA Enforcement Report--Recall from Wedgewood Pharmacy on Pentosan Polysulfate Sodium week of September 11, 2013


Enforcement Report - Week of September 11, 2013

     

    Product Detail

Product DescriptionPentosan 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 NumberV-312-2013
ClassificationClass II
Code InfoLot number 20130618@409, Beyond Use Date 12/15/2013
Product Distributed Qty34 units
Reason For RecallRoutine 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 Id66042
Product TypeVeterinary
StatusOngoing
Recalling FirmWedgewood Village Pharmacy, Inc.
CitySwedesboro
StateNJ
CountryUS
Voluntary / MandatedVoluntary: Firm Initiated
Recall Initiation Date2013-06-28
Initial Firm Notification of Consignee or PublicTelephone
Distribution PatternNationwide

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