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Voluntary Withdrawal of Carimune® NF Initiated

URGENT: BIOLOGIC PRODUCT WITHDRAWAL

King of Prussia, PA — 22 February 2007

Subject: Immune Globulin Intravenous (Human)
Carimune® NF, 3 gm
Lot No. 43017-00016

Dear Colleague:

ZLB Behring L.L.C. has voluntarily decided to initiate a withdrawal of Carimune® NF, lot 43017-00016, with expiration date of 11/26/09. This action is being taken with the knowledge of the Food and Drug Administration.

During routine inspection of undistributed lots, we identified vials with glass particles. The subsequent investigation was expanded to include inventory potentially affected by this issue. We have no reports of glass in this lot; however, we are withdrawing lot 43017-00016 as a precautionary measure. No other distributed lots are affected by this issue.

This batch was distributed by ZLB Behring on 7 February 2007. Our records indicate that you have been shipped this lot of Carimune® NF:

  NDC Number: 44206-416-03
Lot Numbers: 43017-00016
Size: 3 gm
Expiration Date: 11/26/09

This withdrawal is to the pharmacy level.

Please examine your inventories of Carimune® NF for lot 43017-00016. If there is any stock of this lot on hand, please immediately discontinue its distribution and use. Healthcare providers and homecare companies should contact their customers and advise them to return this lot of Carimune® NF to ZLB Behring. If you have any vials of this lot of Carimune® NF, please return them to ZLB Behring at once.

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

1.) If you have any inventory of Carimune® NF, lot 43017-00016 , please complete the enclosed Returned Goods Form. Return the completed Returned Goods Form and all vials in inventory of Carimune® NF, lot 43017-00016, to the following address:
  ZLB Behring L.L.C.
Attention: Carimune® NF Withdrawal
1201 N. Kinzie
Bradley, IL 60915
2.) If you have further distributed this lot, you should notify your customers to the pharmacy level.

Customers who purchased product directly from ZLB Behring will be credited for every returned vial of inventory of Carimune® NF, lot 43017-00016, and ZLB Behring shall bear the shipping costs. Customers who purchased product through a distributor will be credited through their distributor. In addition, ZLB Behring will provide an equivalent replacement vial to the direct purchaser for each returned vial, for the same price as charged for vials from lot 43017-00016, should the direct purchaser desire the replacement.

PLEASE NOTE THAT RETURNS ARE LIMITED TO INVENTORY OF CARIMUNE® NF, LOT 43017-00016 ONLY. THERE WILL BE NO CREDIT GIVEN FOR RETURNS OF ANY OTHER LOT OF CARIMUNE® NF 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,

Karen Etchberger, Ph.D.

Senior Vice-President, Global Quality

CRP16-05-0001 05/2016
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