Merck is issuing a voluntary recall of one lot of Gardasil vaccines due to the risk that some vials of the vaccine may contain glass particles, according to a statement released today by the pharmaceutical company.
The company estimates that only 10 of the 743,360 vials in the lot may have been affected by the incident, which was the result of a breakdown in production. A medical assessment conducted by Merck concluded that if a patient were to receive one of the contaminated vaccines, they had a “remote risk” of experiencing a reaction at the injection site.
This lot of vaccines was distributed between August 20, 2013 and October 9, 2013. The Centers for Disease Control and Prevention (CDC) said that it purchased 350,000 doses of Gardasil from this lot for their own vaccination programs.
"Vaccines from the affected lot were distributed between August 20, 2013, and October 9, 2013. No other lots are affected," the agency said in a statement released Friday. "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)."
So far, no injuries have been reported related to the contaminated vaccines, according to the CDC. People who received a vaccine from the contaminated lot do not need to be revaccinated, and the sterility of the vaccine was not affected, according to Merck.
Merck said it is in the process of contacting customers who purchased vaccines from this lot, # J007354, which was distributed in the United States and Puerto Rico.
Gardasil protects against certain strains of human papillomavirus (HPV), which can cause cervical cancer in women. The CDC added that it continues to recommend that all preteen girls and boys receive three doses of the vaccine at age 11 or 12 years old.