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Press Release

One Lot of HPV Vaccine Recalled by Manufacturer
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Immunization Program
Publish Date:
December 20, 2013

Concord, NH – The New Hampshire Division of Public Health Services (DPHS) at the Department of Health and Human Services learned today that Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., announced a voluntary recall of one lot of Gardasil vaccine (NDC 00006-4045-41; Lot # J007354). This is the vaccine against the human papillomavirus (HPV), which can cause cervical cancer in women. This voluntary recall is being conducted due to the potential for a limited number of vials in this lot to contain glass particles.

This lot was distributed to adult healthcare providers that purchased the vaccine directly from Merck and through the Immunization Program at DPHS for distribution between August 20, 2013 and October 9, 2013. Approximately 900 state-supplied doses have been administered in New Hampshire, but there is no way to know how many doses were purchased by providers directly from Merck Sharp & Dohme. No other distributed lots of Merck product are affected. The providers who received the vaccine through the New Hampshire Immunization Program were contacted this afternoon.

This voluntary recall is being conducted due to the potential for a limited 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 10 of those vials may have glass particles in them. If a vaccine containing glass particles is administered to a patient, there is a remote risk of an injection site reaction. The sterility of the vaccine has not been impacted.

“This is an unfortunate occurrence,” said Dr. José Montero, Director of Public Health, “but if you or someone you know has received an HPV vaccine during this timeframe but have had no problems subsequently, there is no reason to worry. According to Merck, if the product from this lot has been administered, revaccination is not necessary. Though the risk is small, we want to make sure that people who may have been impacted by this are notified out of an abundance of caution. It is important that every person who has started the HPV series continue with the second and third dose.”

According to the Centers for Disease Control and Prevention (CDC), no injuries have been reported related to this lot of vaccine. If you have further concerns about this lot of vaccine, visit the Merck website at https://www.merckvaccines.com/is-bin/INTERSHOP.enfinity/WFS/Merck-MerckVaccines-Site or the CDC website at http://www.cdc.gov/media/releases/2013/s1220-gardasil-vaccine.html.

 
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