A small number of vials may contain glass particles
Clik here to view.
of ConsumerAffairsImage may be NSFW.
Clik here to view.
Merck is recalling one lot (lot J007354) of Gardasil HPV vaccine [Human Papillomavirus Quadrivalent (types 6, 11, 16, and 18) Vaccine, Recombinant].
The potential exists 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.
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.
Merck says it does 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 affected by this problem.
The Centers for Disease Control and Prevention notes that the HPV vaccine continues to have a strong safety record and continues to recommend that all preteen girls and boys receive three doses of the vaccine at age 11 or 12 years.
