- Copyright © 2013, The American Academy of Pediatrics
Merck has implemented a voluntary recall of one lot of Gardasil out of concern that a breakage during the manufacturing process may have led to the presence of glass particles in a small number of vials, the Centers for Disease Control and Prevention (CDC) announced.
Lot J007354 of Gardasil (Human Papillomavirus Quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant) was distributed between Aug. 20 and Oct. 9. The lot contained 743,360 vials of the vaccine. Merck estimates about 10 of those vials may have glass particles in them.
No other lots are affected. People who recently have received an HPV vaccine 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, such as redness or swelling at the injection site, may occur after vaccination. Other than mild reactions, no adverse events related to this lot of HPV vaccine have yet been reported. CDC does not expect delayed side effects to occur.
The vaccine’s effectiveness is not impacted by this problem. Clinicians’ offices who have administered this vaccine do not need to re-vaccinate anyone.
Merck is contacting offices or clinics who received vaccine from lot J007354 and providing them with procedures to return any of the vaccine that has not been used. This voluntary recall does not affect the supply of vaccine.
For more information visit http://www.cdc.gov/vaccinesafety/Vaccines/HPV/hpv_gardasil_recall.html or www.merckvaccines.com.