DTaP Vaccine Voluntary Recall

What vaccine has been recalled?

A single lot of children's diphtheria, tetanus, and acellular pertussis (DTaP) vaccine from vaccine manufacturer Pasteur-Merieux Connaught Tripedia Lot #0916490. The manufacturer is notifying health care providers who received the recalled lot of vaccine.

Why was this vaccine recalled?

During routine potency testing done to check the "shelf -life" of the vaccine, the manufacturer determined that the diphtheria portion of this vaccine was subpotent (weaker than should be) and voluntarily issued the recall. The diphtheria part of this vaccine lot had passed the potency test before the vaccine was released.

Has vaccine from this lot already been used?

Yes. Children have been vaccinated with vaccine from this lot. The lot was shipped to health care providers between February and June 1998 and would have been given to children since then. Any remaining vaccine from this lot should not be used and should be returned to the manufacturer.

Is vaccine from this lot safe?

Yes. This vaccine lot is as safe as any other DTaP vaccine--it will not hurt children who received it.

Should children who've received one or more doses of this vaccine be revaccinated with a vaccine dose from a different lot of DTaP?

The CDC, American Academy of Pediatrics and the American Academy of Family Physicians agree: Most children do not require an additional vaccination. Children who received two or more doses of Tripedia Lot #091-6490 in their primary series (first three shots) and have not yet received their fourth dose in the series AND who are traveling to an area where diphtheria is commonly occurring may benefit from an additional dose of DTaP. Additional vaccination for children who received one, two or three doses of vaccine from this lot is not necessary if they will not be traveling to countries where diphtheria is occurring.

How can parents determine whether their child received vaccine from this lot or not?

If a child is not going to be traveling abroad, parents do not need to seek this information. If parents will be traveling abroad, they should ask their child's immunization provider. If parents are curious about what lot their child received, but not traveling abroad, they may check with their child's health care provider at the next scheduled office visit.

Important websites or telephone numbers for additional information:

Parents should contact their physicians for further information.

Pasteur-Merieux Connaught: Health professionals may call 1-800-325-7709

Food and Drug Administration: http://www.fda.gov/bbs/topics/answers/ANS00938.html

CDC Travelers Health Information for information on countries where diphtheria is occurring: http://www.cdc.gov/travel

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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES