Merck recalls HPV vaccine Gardasil because shots may contain broken glass
on December 27, 2013 at 11:03 PM, updated December 27, 2013 at 11:04 PM
The pharmaceutical company Merck is recalling nearly 750,000 doses of its HPV vaccine because a handful may be contaminated with broken glass.
The U.S. Centers for Disease Control and Prevention described the origin of the glass breakage as "an isolated problem in the vaccine manufacturing process."
Merck notified the CDC on Dec. 16 that it was voluntarily recalling the vials.
The suspect vaccines were distributed to 40 states — including New Jersey — and Puerto Rico, according to a Merck spokesman.
The company emphasized it isn’t certain the specks of glass would be small enough to fit through any needle injecting the vaccine.
If any were, they might cause irritation at the site of the shot, but would not reduce the vaccine’s efficacy, according to the CDC.
The CDC doesn’t believe there would be any delayed reaction or side effects.
"To date, no adverse events related to this lot of HPV vaccine have been reported other than these types of mild reactions," the CDC statement said.
The Merck vaccine, known as Gardasil, is recommended for girls and young woman to prevent cervical and other cancers caused by some strains of the human papilloma virus.
It is also recommended for boys and young men to guard against genital warts.
According to Merck officials, 11.2 million vials were distributed in 2013.
The problematic batch of Gardasil, some 743,360 vials, was distributed between Aug. 20 and Oct. 9. Merck told the CDC it estimates as many as 10 vials could contain broken glass.
The company is contacting clinics and doctors offices that received doses from the problematic lot of vaccines. The notification will include information on how to return any unused doses.
Health care professionals who already administered vaccines from this lot do not need to re-vaccinate those patients.
And patients who received the vaccine during the August to October period don’t need to do anything in response to the recall.
The problem occurred at Merck’s manufacturing facility in West Point, Pa., a Merck spokesman said. The recall does not affect the available supply of the vaccine, according to the CDC.