Pharmaceutical giant, Merck, has voluntarily recalled one lot of its human papillomavirus (HPV) vaccine, Gardasil, in the United States, including Puerto Rico. The recall is due to the potential for a limited number of vials to contain small glass particles.
The recall affects 743,360 single dose 0.5mL vials which were distributed by Merck between August 20, 2013 and October 9, 2013. Merck estimates that the issue may have affected approximately 10 vials out of the 743,360 being recalled.
“We are fully committed to ensuring the high quality of our vaccines,” said Greg Guyer, Ph.D., senior vice president, Global Quality, Merck Manufacturing Division. “We know that our vaccines can play an important role in the nation’s public health system.”
Merck notes that the recall does not affect any other lots of Gardasil or any other vaccines manufactured by the company.
The US Centers for Disease Control and Prevention issued a media statement Friday concerning the recall.
According to Merck, Gardasil is indicated in the United States for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.
Gardasil is also approved for use in boys and men 9 through 26 years of age for the prevention of anal cancer caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.
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