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DATE RECALL INITIATED: January 27, 1999 PRODUCT / LOT NUMBER / EXPIRATION DATE: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Tripedia: 0916490 06/08/1999 MANUFACTURER: Connaught Laboratories, Inc. Swiftwater, PA REASON: In the course of routine stability testing, Connaught learned that the potency of the diphtheria component in the above mentioned lot of Tripedia had fallen below specification. Although this product met all specifications at the time of release, the potency of the diphtheria component fell below specification prior to the product's expiration date. The potency of the tetanus and pertussis components continues to be satisfactory. Because diphtheria is very rare in the United States, the health risk to patients who have received this subpotent lot is minimal, especially if the child is not expected to travel outside of the United States. Any questions or medical inquiries can be directed to Connaught's Medical Affairs department at 1-800-325-7709. 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 11, 2002

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