(SafetyAlerts) - The FDA has released the following information.
PRODUCT
Vicodin HP Tablets (hydromorphone bitartrate and acetaminophen tablets, USP), 10mg/660mg, 500 count bottles, Rx only. Recall # D-048-4.
CODE
Lot 03VICH5004, Exp. Date June 2006.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter dated October 21, 2003. FDA initiated recall is ongoing.
REASON
Mislabeling: Extended expiration date-product incorrectly declares expiration date as 6/2006 rather than the correct date of 6/2005.
VOLUME OF PRODUCT IN COMMERCE
108 bottles.
DISTRIBUTION
Nationwide.
PRODUCT
Vicodin HP Tablets (hydromorphone bitartrate and acetaminophen tablets, USP), 10mg/660mg, 500 count bottles, Rx only. Recall # D-048-4.
CODE
Lot 03VICH5004, Exp. Date June 2006.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter dated October 21, 2003. FDA initiated recall is ongoing.
REASON
Mislabeling: Extended expiration date-product incorrectly declares expiration date as 6/2006 rather than the correct date of 6/2005.
VOLUME OF PRODUCT IN COMMERCE
108 bottles.
DISTRIBUTION
Nationwide.
