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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]

 

DATE NOTIFICATION INITIATED:  December 19, 2013
 
PRODUCT / LOT NUMBER
 
GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]; Lot J007354 
 
MANUFACTURER: 
 
Merck Sharp & Dohme Corporation
West Point, PA
 
REASON:
 
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (Merck) is initiating a voluntary recall due to the potential for a limited number of vials to contain glass particles. This lot was distributed by Merck between August 20, 2013 and October 9, 2013. No other distributed lots of Merck product are affected.
 
Merck’s investigation concluded that for certain vials in the affected lot, the potential exists for small glass particles to be present in the vial. If a vaccine containing glass particles is administered to a patient, there is a remote risk of an injection site reaction. The sterility of the vaccine has not been impacted. If product from this lot has been administered, revaccination is not necessary. The supply of GARDASIL will not be impacted by this recall. 
 
Customers are asked to examine their inventory and follow the steps outlined in the notification.

 
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.