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DATE FIELD CORRECTION INITIATED:
July 1, 1999
PRODUCTS / LOT NUMBERS / EXPIRATION DATES:
Immune Globulin Intravenous (Human), Venoglobulin-S, 10% solution:
GR8041A 07/21/2000
GR8041AB 07/21/2000
GR8042A 07/26/2000
GR8042AB 07/26/2000
GR8043A 07/28/2000
GR8044A 07/31/2000
GR8044AB 07/31/2000
GR8045A 08/02/2000
GR8046A 08/05/2000
GR8047A 08/10/2000
GR8048A 08/17/2000
GR8049A 08/20/2000
GR8050A 08/21/2000
GR8050AB 08/21/2000
GR8051A 08/23/2000
GR8051AB 08/23/2000
GR8052A 08/26/2000
GR8052AB 08/26/2000
GR8053A 08/30/2000
GR8053AB 08/30/2000
GR8053AC 08/30/2000
GR8054A 09/03/2000
GR8054AB 09/03/2000
GR8054AC 09/03/2000
GR8055A 09/05/2000
GR8055AB 09/05/2000
GR8056A 09/07/2000
GR8057A 09/10/2000
GR8057AB 09/10/2000
GR8061A 09/11/2000
GR8061AB 09/11/2000
GR8062A 09/13/2000
GR8062AB 09/13/2000
GR8062AC 09/13/2000
GR8063A 09/15/2000
GR8064A 09/26/2000
GR8065A 09/24/2000
GR8066A 09/28/2000
GR8067A 09/29/2000
GR8068A 10/05/2000
GR8069A 10/07/2000
GR8070A 10/09/2000
GR8071A 10/11/2000
GR8072A 10/15/2000
GR8073A 10/17/2000
GR8083A 12/31/2000
GR8084A 01/03/2001
GR9001A 01/06/2001
GR9002A 01/08/2001
GR9003A 01/10/2001
GR9004A 01/12/2001
GR9005A 01/14/2001
GR9006A 01/16/2001
GR9007A 01/18/2001
GR9008A 01/26/2001
GR9009A 01/28/2001
GR9010A 02/04/2001
GR9011A 02/01/2001
GR9012A 02/11/2001
GR9013A 02/10/2001
GR9014A 02/14/2001
GR9015A 02/15/2001
GR9016A 02/17/2001
GR9018A 02/20/2001
GR9019A 02/22/2001
GR9020A 02/25/2001
GR9021A 03/04/2001
GR9022A 03/07/2001
GR9023A 03/09/2001
GR9024A 03/11/2001
GR9025A 03/12/2001
GR9026A 03/14/2001
GR9027A 03/16/2001
GR9029A 03/19/2001
GR9034A 04/02/2001
GR9035A 04/04/2001
GR9036A 04/06/2001
MANUFACTURER:
Alpha Therapeutic Corporation
Los Angeles, CA
REASON:
Recent stability studies have shown that the anticomplementary activity (ACA) of Venoglobulin-S, 10% may not remain stable for its labeled dating period of 24 months when stored at 25°C. Alpha Therapeutic Corporation has determined that, as a precautionary measure, lots of Venoglobulin-S, 10% labeled with a storage temperature of "at or below 25°C" should be relabeled with an expiration date of 12 months after manufacture, a change from the current 24 month dating period. Alpha Therapeutic Corporation will provide vial and carton labels to affix over the current label on any product remaining in inventory from the above-mentioned lots. There has been no increase in the incidence of adverse events reported with this product, and use of this product may continue.
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.
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