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DATE RECALL INITIATED: December 10, 2001 PRODUCT: 50 U / 1 mL, single-dose prefilled syringe LOT NUMBER / EXPIRATION DATE: 0030L 10/29/2003 0507L 02/17/2004 0460L 10/30/2003 0525L 02/18/2004 0031L 11/05/2003 0524L 02/18/2004 0031LSA1 11/05/2003 0523L 02/15/2004 25 U / 0.5 mL, single-dose prefilled syringe LOT NUMBER / EXPIRATION DATE: 1761H 11/02/2001 1802J 10/24/2002 1937H 11/16/2001 0118K 12/22/2002 0159J 12/08/2001 0309K 12/22/2002 0158J 01/11/2002 0330K 12/22/2002 0115K 02/17/2002 0547K 12/23/2002 0580J 02/19/2002 0680K 02/09/2003 0746J 03/04/2002 0548K 02/10/2003 1407J 03/10/2002 0692K 03/29/2003 0745J 03/10/2002 0852K 04/02/2003 0952J 04/13/2002 1200K 05/31/2003 1915J 04/13/2002 0714L 06/02/2003 1751J 05/16/2002 1178K 06/03/2003 0117K 05/17/2002 0430L 08/25/2003 1750J 05/18/2002 1628K 08/25/2003 1871J 10/18/2002 0715L 09/20/2003 1802JSA2 10/24/2002 0716L 09/20/2003 MANUFACTURER: Merck & Co., Inc. West Point, PA REASON: Some syringes may have antigen levels below the minimum product specification limit. As a result, a possibility exists that persons vaccinated with Hepatitis A Vaccine, Inactivated, VAQTA, in prefilled syringes from the indicated lots may be insufficiently protected against hepatitis A. Patients who may have received doses from indicated lots would have been vaccinated after May 29, 2001 with the adult formulation, (50U / 1 mL), and after June 16, 1999 with the pediatric/adolescent formulation, (25U / 0.5 mL). Individuals who may have been vaccinated with these lots should consult their health care provider. 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.

Updated April 4, 2002

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