[MOL] Hmmune Globulin Intravenous Recall Alert! [01080] Medicine On Line


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[MOL] Hmmune Globulin Intravenous Recall Alert!



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.