Guest guest Posted August 30, 1999 Report Share Posted August 30, 1999 Firm Initiated Recall of Immune Globulin Intravenous (Human) 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. 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. Quote Link to comment Share on other sites More sharing options...
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