Biologic Product Withdrawal of Carimune® NF Immune Globulin Intravenous
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, an no other distributed lots are affected by this issue.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.