A key goal of Pasteur Merieux Connaught is to communicate effectively with our customers whenever corrective action is required. This letter is to notify you of a voluntary recall of a single lot of our Tripedia vaccine.

In the course of routine stability testing, we recently learned that the potency of the diphtheria component in a single 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. Our records indicate that you received product from this particular lot. We are initiating a voluntary recall of Tripedia lot number 0916490 and we will replace any remaining inventory that you have on hand or that you may have distributed to other healthcare providers. Please stop using this lot immediately and return all remaining inventories. No other Tripedia lots are affected.

Because diphtheria is very rare in the U.S., we believe that the health risk to patients who have received the subpotent lot is minimal. Recommendations concerning special populations of children who might receive a supplemental dose of vaccine will be forthcoming in the next few days. We request that physicians be especially diligent in ensuring that children who received this lot of Tripedia are administered subsequent doses of DTaP vaccine on the regular schedule and in a timely manner. Our Medical Affairs department is available at 1-800-325-7709 to address any medical inquiries that you may have in this regard.

Please examine your inventory and indicate on the enclosed reply card whether or not you have any remaining inventory of the above referenced lot. In the event that you do have inventory, do not use these doses and please contact us at 1-800-350-6984 so that we can promptly replace any such product with a new lot of Tripedia. Please return the card whether or not you have remaining inventory of this lot to help us determine that all existing stocks have been returned. Enclosed with this letter are a postage-paid shipping label and a packing list with instructions on how to return the product.

We can also provide you with additional quantities of these materials to enable you to disseminate this notice to any healthcare providers who received material from this particular lot. Alternatively, we can send this notice directly to these providers if you prefer. Please contact use at 1-800-350-6984 and we will be glad to assist you in this effort.

This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration. You are a valued Pasteur Merieux Connaught customer and we greatly appreciate your cooperation in these efforts. Your Pasteur Merieux Connaught representative is also available to provide any assistance you may desire to facilitate your return and replacement activities. Our greatest concerns remain meeting your needs and ensuring that your patients receive the highest levels of immunization. Once again, feel free to contact our Medical Affairs department (1-800-325-7709) if you have questions. Please accept our apologies for any inconvenience we may have caused.

Pasteur Merieux Connaught is committed to supplying our customers with products that are safe and effective, properly labeled and produced to meet appropriate standards of potency, purity and safety. Whenever we fall short of our goal, we will take prompt corrective action.

Very truly yours,

Carlton Meschievitz, M.D.
Vice President , Scientific & Medical Affairs