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Voluntary Recall of One Lot of Gardasil HPV Vaccine

During the past several months, we at CDC have been working hard to take steps to increase HPV vaccination coverage among 11-12 year olds, including actively communicating with clinicians and parents about the benefits and safety of this cancer-preventing vaccine. We want to also be open and timely in sharing any problems or concerns related to HPV vaccines as they arise.

On December 16, 2013 CDC was informed by Merck that the company planned to implement a voluntary recall of one lot (lot J007354) of Gardasil® [Human Papillomavirus Quadrivalent (types 6, 11, 16, and 18) Vaccine, Recombinant], due to the potential for a small number of vials to contain glass particles as a result of breakage during the manufacturing process. There were 743,360 vials in the affected lot. Merck estimates that approximately ten of those vials could have glass particles in them. Vaccines from the affected lot were distributed between August 20, 2013, and October 9, 2013. No other lots are affected.

What This Means For Anyone Who Has Recently Received HPV Vaccine

People who have recently received an HPV vaccine or their parents do not need to take any action as a result of this recall. If a vaccine containing glass particles (tiny enough to get through a needle) is given to a patient, mild reactions routinely seen after vaccination may occur (for instance, redness or swelling at the injection site). To date, no adverse events related to this lot of HPV vaccine have been reported other than these types of mild reactions. We do not expect delayed side effects to occur. If you or your child recently received HPV vaccination, there is no need to be revaccinated. The vaccine's effectiveness is not impacted by this problem.

What This Means For Clinicians Who Administer HPV Vaccines

Merck is contacting offices or clinics who received vaccine from lot J007354 and providing them with procedures to return any of the vaccine that has not been used. This voluntary recall does not affect the supply of vaccine. Clinicians' offices who have administered this vaccine do not need to re-vaccinate anyone. As always, clinicians should report adverse events following vaccination to the Vaccine Adverse Event Reporting System (VAERS).

This recall was caused by an isolated problem in the vaccine manufacturing process. HPV vaccine continues to have a strong safety record and CDC continues to recommend that all preteen girls and boys receive three doses of the vaccine at age 11 or 12 years.

SOURCE: CDC, December 20, 2013





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