FDA announces VAQTA Hepatitis A Vaccine is voluntarily recalled

    The FDA recently announced that Merck & Co., Inc. has voluntarily recalled specified lots of VAQTA Hepatitis A Vaccine, in prefilled syringes.  Re-tests have indicated a decreased antigen content in some syringes below the estimated minimum specification.  Patients who may have received these doses would have been vaccinated after May 29, 2001 with the adult formulation (50U/1mL) and after August 9, 1999 with the pediatric/adolescent formulation (25U/0.5mL).

     Further information on this recall, including guidelines for antibody testing and revaccination of patients may be obtained at the Food and Drug Administration website:  www.fda.gov  or www.fda.gov/medwatch/SAFETY/2001/safety01.htm (information will be listed under biologics or you may do a search for VAQTA Hepatitis A Vaccine)

A table of affected lots may found at: www.fda.gov/cber/recalls/merhav121001.htm