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August 20, 2003

Barr Laboratories Has Recalled Nortrel 7/7/7 Oral Contraceptive Tablets

(SafetyAlerts) - The Food and Drug Administration (FDA) released the following information.

Nortrel 7/7/7 Oral Contraceptive Tablets (norethindrone and ethinyl estradiol tablets, USP - triphasic regimen), 28 DAY REGIMEN, 6 blister card, 28 Tablets Each, Rx only, Each light yellow tablet contains 0.5mg norethindrone and 0.035mg ethinyl estradiol. Each blue tablet contains 0.75mg norethindrone and 0.035mg ethinyl estradiol. Each peach tablet contains 1mg norethindrone and 0.035mg ethinyl estradiol. Each white tablet contains inert ingredients.
Recall # D-302-3.

Lots 290122001, 290122002, 290122003.

Barr Laboratories, Inc., Pomona, NY, by press release and letter on July 9, 2003. Firm initiated recall is ongoing.

Mispacked; color-coded tablets are packaged in improper sequence as white, peach, blue, yellow rather than in correct sequence as yellow, blue, peach, white.

469,938 blister cards.

Nationwide, and Puerto Rico.

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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.