Voluntary Recall Of Gardasil Issued, HPV Vaccine May Be Contaminated With Glass
ByMerck has issued a voluntary recall of one lot of Gardasil vaccine due to fears that some vials of the vaccine may contain glass particles, health officials announced late Friday.
The pharmaceutical company said they were contaminated during a breakdown in the breakdown of production. They estimate that only 10 of the 743,360 vials in the lot may have been affected, Fox News reported.
The vaccine is given to protect against human papillomavirus, or HPV, which can cause cervical cancer.
If a patient were to receive one of the contaminated vaccines, they had a "remote risk" of experiencing a reaction at the injection site, Merck concluded after conducting a medical assessment.
Vaccines from the affected lot were distributed between August 20, 2013, and October 9, 2013. In a statement, Merck said no other lots were affected. The company was unable to say how many health care providers received doses from the batch, the Boston Globe reported.
Barbara Reynolds, spokeswoman for the Center for Disease Control, told the Boston Globe the agency has received no reports of injuries or adverse health effects related to the vaccine.
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 the CDC.
"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)," the CDC said in a statement.
CDC said Merck is in the process of contacting customers who purchased vaccines from this lot, # J007354, which was distributed in the United States and Puerto Rico.