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SafetyAlerts
September 6, 2001

Merck Sharp & Dohme Quimica de PR Recalls Vioxx

Arecibo, PR.  (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Merck Sharp & Dohme Quimica de PR (Arecibo Pharmaceutical Operation), is recalling Vioxx 50 mg Tablets (Rofecoxib Tablets), NDC 0006-01124-68, solid oral dosage form, packaged in plastic bottles/plastic lid of 100.

This is the first public notice of this Class llI recall issued by the FDA.

RECALL NUMBER, PRODUCT AND CODE:
D-278-1 Vioxx 50 mg Tablets (Rofecoxib Tablets), NDC 0006-01124-68, solid oral dosage form, packaged in plastic bottles/plastic lid of 100.

CODE:
Lot No. Exp. Date
J9310 Nov-01
J9311 Nov-01
J9312 Nov-01
J9313 Nov-01
J9314 Nov-01
K2013 Aug-01
K2014 Aug-01
K2015 Mar-02
K2016 Mar-02
K2021 Mar-02
K2022 Mar-02
K2026 May-02
K2031 May-02
K2033 May-02
K2034 May-02
K2036 Mar-02
K2037 Nov-02
K2708 Nov-02
K2709 Nov-02
L3164 Nov-02
L3165 Nov-02
L3166 Nov-02
L3174 Nov-02
L3175 Jan-03
L3176 Jan-03
L3179 Jan-03
L3180 Jan-03
L3181 Jan-03
L3182 Feb-03

REASON:
MISLABELING; Product fails to declare container is a bulk package not intended for dispensing and not child resistant.

MANUFACTURER/RECALLING FIRM:
Merck Sharp & Dohme Quimica de PR (Arecibo Pharmaceutical Operation), Arecibo, PR.

RECALLED BY:
Manufacturer, by letter on June 28, 2001.

FIRM INITIATED RECALL:
Ongoing.

DISTRIBUTION:
Nationwide.

QUANTITY:
622,427 units.

 Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

 
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Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.