Biological Product Withdrawal of Carimune NF Immune Globulin Intravenous-ZLB Behring

DATE WITHDRAWAL INITIATED:

February 21, 2007

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Carimune® NF Immune Globulin Intravenous
Lot Number: 43017-0016
Expiration: 11/26/2009

MANUFACTURER:

ZLB Behring
Bern, Switzerland

REASON:

During routine inspection of undistributed lots, ZLB identified vials with glass particles. The subsequent investigation was expanded to include inventory potentially affected by this issue. To date, ZLB has had no reports of glass, and no other distributed lots are affected by this issue.