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/srcigiv082099.htm


Firm Initiated Recall of Immune Globulin Intravenous (Human)
________________________________________________________
DATE RECALL INITIATED:	August 20, 1999

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Immune Globulin Intravenous (Human), Panglobulin:
01839-00012   07/31/2000
01839-00023   10/31/2000


MANUFACTURER:

Central Laboratory Blood Transfusion Service Swiss Red Cross
Bern, Switzerland

DISTRIBUTORS:

Immune Globulin Intravenous (Human), Panglobulin:
American Red Cross NHQ
Rosslyn, VA

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 8/24/99
notification.

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