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Childhood Vaccine Voluntarily Recalled

Posted by Jane Akre
Thursday, December 13, 2007 10:35 AM EST
Category: Major Medical, Protecting Your Family
Tags: Defective and Dangerous Products, FDA and Prescription Drugs, Defective Drugs


  • CDC Q & A and product recall list
  • VAERS Vaccine Adverse Event Reporting System
  • Merck 1-800-672-6372

Merck is recalling 1.2 million doses of a vaccine that protects against bacterial meningitis in children under the age of five.

The voluntary recall began Wednesday after the drug giant found a bacterial contamination, Bacillus cereus on vaccine manufacturing equipment at its Pennsylvania plant.

In a statement, Merck says the contamination did not turn up any vaccines but the company "cannot assure sterility of these specific vaccine lots." 

Physicians are advised not to give any vaccines from the lots recalled which are listed on the CDC web site.

All of the lots except one were distributed throughout the U.S. beginning last April.

The vaccine protects against Hib disease (Haemophilus influenza type b) which can cause infections of the eye, ear and sinuses  as well as pneumonia and meningitis. The drug is known as PedvaxHIB and Comvax vaccine which also protects against hepatitis B.

Merck alerted the CDC and the FDA about the recall.

Parents should look for any reaction to the vaccine up to one week after receiving it including any sign of infection at the injection site according to Merck.  

Hib was a leading cause of death before vaccinations were mandated a decade ago killing 1 in 20 among 20,000 cases per year. Now the CDC reports there are fewer than 100 documented cases in the U.S.

A shortage of the Hib vaccine is expected while health officials temporarily dip into stockpiles to meet the need. 

Merck is the New Jersey-based company that last month agreed to pay $4.85 billion to settle outstanding Vioxx claims. #


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