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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448
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