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Voluntary Withdrawal of Monoclate-P® Initiated

URGENT: BIOLOGIC PRODUCT WITHDRAWAL

King of Prussia, PA — 19 August 2008

URGENT: BIOLOGIC RECALL

Subject: Monoclate-P®, 1000 Unit
             Antihemophilic Factor, Human
             Lot Numbers J91504, J91604, J91705 and J91806

Dear Colleague:

CSL Behring L.L.C. has voluntarily decided to initiate a recall of Monoclate-P®, 1000 Unit, lots J91504, J91604, J91705 and J91806, with expiration dates of April 25, April 30, May 2, and June 9, 2010, respectively. This action is being taken with the knowledge of the Food and Drug Administration.

These lots are being voluntarily recalled as a precautionary measure. These lots do not meet the potency specification when stored for three months at 5º C. As of this date, there are no technical complaints or adverse events reported against any of these lots. CSL Behring is requesting that the use of these lots be immediately discontinued and the product be returned to the company.

Vials from all four batches have been distributed beginning on August 4, 2008. Our records indicate that you have been shipped vials from one of these lots of Monoclate-P®.

NDC No. Lot Potency Expiration Date
0053-7656-04 J91504 925 IU April 25, 2010
0053-7656-04 J91604 960 IU April 30, 2010
0053-7656-04 J91705 975 IU May 02, 2010
0053-7656-04 J91806 960 IU June 09, 2010

This recall is to the pharmacy level.

Please examine your inventory of Monoclate-P®, 1000 Unit for lots J91504, J91604, J91705 and J91806. Please immediately discontinue distribution and use of any on-hand stock from these lots. Return that stock to CSL Behring.

Healthcare providers and homecare companies should contact their customers and advise them to return these lots of Monoclate-P® to CSL Behring.

Regardless of whether or not you have any inventory or product from these lots, please immediately take the following actions:

    1. If you have any inventory of Monoclate-P®, 1000 Unit lots J91504, J91604, J91705 and J91806, please complete the Returned Goods Form. Return the completed Returned Goods Form and all vials in inventory of Monoclate-P®, 1000 Unit lots of J91504, J91604, J91705 and J91806, to the following address:

      CSL Behring, L.L.C.
      Attention: Monoclate-P®, 1000 Unit Recall
      2101 N. Kinzie
      Bradley, IL 60915

    2. If you have further distributed these lots, you should notify your customers to the pharmacy level.

Customers who have purchased product directly from CSL Behring will be credited for every returned vial of inventory of Monoclate-P®, 1000 Unit lots J91504, J91604, J91705 and J91806, and CSL Behring shall bear the shipping costs. Customers who purchased product through a healthcare provider or a homecare company will be credited through their healthcare provider or homecare company, respectively.

PLEASE NOTE THAT RETURNS ARE LIMITED TO INVENTORY OF MONOCLATE-P®, 1000 UNIT FOR LOTS J91504, J91604, J91705 and J91806 ONLY. THERE WILL BE NO CREDIT GIVEN FOR RETURNS OF ANY OTHER LOTS OF MONOCLATE-P® THAT YOU HAVE IN INVENTORY OR RETURNED BY YOUR CUSTOMERS.

If you have any questions concerning product returns, please call Customer Support at 1-800-683-1288. For Medical Information questions, please call 1-800-504-5434.

Thank you for your cooperation in this matter.

Sincerely,
Jeffrey Alcorn
Senior Director, Quality

CC: Kathleen Haas (CBER Recall Coordinator)
       FDA Recall File - Kankakee

 

 

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