Recall of Immune Globulin Intravenous (Human)

[Robert Marshall <marshalr@OHSU.EDU>]

This document is available on the internet at
http://www.fda.gov/cber/fprecalls/srcigiv082499.htm

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Firm Initiated Recall of Immune Globulin Intravenous (Human)
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DATE RECALL INITIATED:	August 24, 1999

PRODUCT / LOT NUMBER / QC LOT NUMBER* / EXPIRATION DATE:

Immune Globulin Intravenous (Human), Sandoglobulin:
7.409.561.0  561Z4409	07/2000
7.409.561.0	 561Z4098	07/2000
8.409.362.0	 047A6478	04/2001
8.409.433.0	 053A6697	06/2000
8.409.433.0  053A6698   06/2000
9.401.255.0	 085B9813	01/2001
8.409.599.0	 072A8945	10/2000
8.409.599.0	 072A8946	10/2000
8.409.208.0	 029A6093	12/2000
9.409.229.0	 080B9812	12/2000
9.401.292.0	 090B0161	01/2001

*QC lot numbers appear on the outer folding carton in which the
12 gram bottle is packaged.

MANUFACTURER:

Central Laboratory Blood Transfusion Service Swiss Red Cross
Bern, Switzerland

DISTRIBUTORS:

Immune Globulin Intravenous (Human), Sandoglobulin:
Novartis Pharmaceuticals Corporation
East Hanover, NJ/Suffern, NY

REASON:

Central Laboratory Blood Transfusion Service Swiss Red Cross has
initiated this recall due to the detection that certain lots of
Immune Globulin Intravenous (IGIV) have been released which may
contain bottles having residual moisture content greater than the
specified limit of 2% residual moisture.  No adverse events have
been reported related to this issue.

Additional lots of recalled product are included in the 8/20/99
notification.
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