The CDC was informed by Merck that the company planned to implement a voluntary recall of one lot (lot J007354) of Gardasil [Human Papillomavirus Quadrivalent (types 6, 11, 16, and 18) Vaccine, Recombinant], due to the potential 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 were 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). The CDC does not expect delayed side effects to occur. Revaccination is not necessary. The vaccine’s effectiveness is not impacted by this problem.
This recall was caused by an isolated problem in the vaccine manufacturing process. HPV vaccine continues to have a strong safety record and the CDC continues to recommend that all preteen girls and boys receive three doses of the cancer preventing vaccine at age 11 or 12 years.
See the Recall
See the CDC Announcement
See also Medical Law Perspectives, January 2013 Report: Vaccines: An Ounce of Prevention May Lead to a Pound of Injury