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Merck Voluntarily Recalls One Lot of Gardasil
  Small Number of Vials May Contain Glass Particles
By Anna Prior
Dec. 20, 2013 4:15 p.m. ET
Merck & Co. said it is voluntarily recalling one lot of its Gardasil vaccine for human papillomavirus, or HPV, due to the potential for a small number of vials to contain glass particles as a result of breakage during the manufacturing process.
The pharmaceutical giant said the lot was distributed between Aug. 20 and Oct. 9, and that no other distributed lots of Merck product are affected.
According to the U.S. Centers for Disease Control and Prevention, there were 743,360 vials in the lot, and Merck estimated that roughly 10 of those vials could have glass particles in them.
The CDC said that people who have received the HPV vaccine don't need to take any action as a result of this recall, and that to date no adverse events related to this lot have been reported other than mild reactions, like redness or swelling at the injection site.
Merck is contacting offices or clinics who received the vaccine from the affected lot and providing them with procedures to return any of the vaccine that hasn't been used, said the CDC.
Gardasil, launched in 2006, was the first vaccine to protect against HPV, a sexually transmitted virus that can cause cervical cancer in women and other less-common types of cancer in males and females. The CDC recommends HPV vaccination of boys and girls ages 11 and 12, though it is approved to be given to people ages 9 to 26.
Merck issues voluntary recall of 743,360 vials of Gardasil HPV vaccine
Published December 20, 2013


Gardasil, a Human Papillomavirus vaccine, is displayed in Dallas, Texas March 6, 2007. (REUTERS/Jessica Rinaldi)
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.
Merck Recalls Gardasil HPV Vaccine Batch
Submitted by Daphney Choshi on Sat, 12/21/2013 - 09:37
Pharmaceutical major Merck has issued voluntary recall of HPV vaccine Gardasil vaccine due to fears of contamination of vials with glass particles. The company said that only 10 vials among 743,360 total of the lot (lot no. J007354) could have been affected during the manufacturing process.
The Centers for Disease Control and Prevention had purchased 350,000 vials of HPV vaccine Gardasil for the vaccination program. The company has confirmed that no other lots were impacted due to manufacturing issue. The company is also in process of contacting the customers who purchased vaccines from the lot in Massachusetts and Puerto Rico.
The small glass particles entered some of the vials. The company said that some tiny glass particles, which could get through a needle, can cause swelling at the injection site. The company further said that people who have recently received the HPV vaccine need not worry about the current recall. The impact of recall is only on one lot, which was sold between August 20, 2013 and October 9, 2013. People who have been vaccinated from the contaminated lot, need not take any further action. There is no need for revaccination as the impact was limited to very few vials, even in the contaminated lot # J007354.
As per CDC official Barbara Reynolds, no injuries have been reported so far. However, Reynolds was no able to comment on how the company arrived that only 10 vials may have been contaminated. The only adverse effect of the injection from contaminated vial would be redness and swelling at injection site. CDC is encouraging people to get children below age of 13 to be vaccinated. Gardasil protects against some strains of human papillomavirus (HPV). The virus is major cause of cervical cancer in women. Merck representatives can be contacted at 800-672-6372.
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