Recall of Hepatitis A Vaccine, Inactivated (VAQTA)
(Packaged in single-dose prefilled syringes)

DATE RECALL INITIATED:

December 10, 2001

PRODUCT:

50 U / 1 mL, single-dose prefilled syringe

25 U / 0.5 mL, single-dose prefilled syringe

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.