URGENT: BIOLOGIC WITHDRAWAL INFORMATION
 
Initiated by: ZLB Behring
Event Id: 128
Event Date: 02-21-2007
Therapy: Carimune® NF
 
NDC Number: 44206-416-03
Lot Number: 43017-00016
Size: 3 gram vial
Packaging:   -
Expiration Date: 11-26-2009
 
Reason 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.
 
Action
1) Please examine your inventories of Carimune® NF for lot 43017-00016.
 
2) If there is any stock of this lot on hand, please immediately discontinue
its distribution and use. If you have any vials of this lot of Carimune® NF,
please return them to ZLB Behring at once. 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.
 
3) Contact your physician if you have medical questions.
 
Other Information If you need assistance, please call Stericycle, Inc. at
1-888-UPDATE-U.
 

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