The CDC is alerting the public about a recall of one lot of Gardasil (Quadrivalent human papillomavirus types 6, 11, 16, and 18 vaccine [recombinant]; Merck) due to the potential for some vials to contain glass particles as a result of breakage during the manufacturing process.
If a vaccine containing glass particles is administered to a patient, mild reactions routinely seen after vaccination may occur (eg, redness or swelling at the injection site).
The affected vials are from lot # J007354 and were distributed between August 20, 2013 and October 9, 2013. The effectiveness of the vaccine is not impacted by this problem, therefore healthcare providers do not need to re-vaccinate anyone.
Merck is contacting offices and clinics who received vaccines from the affected lot and is arranging for return of the product. This recall does not affect the supply of the vaccine.
The CDC continues to recommend that all preteen girls and boys receive three doses of the vaccine at age 11 or 12 years.
For more information call (800) 232-4636 or read the CDC statement.