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

MONDAY Dec. 23, 2013, 2013 -- Recall Notification: Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]

ATE NOTIFICATION INITIATED: December 20, 2013

PRODUCT / LOT NUMBER: Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]; Lot J0078354

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.

Source: FDA

Posted: December 2013


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