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SafetyAlerts
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.

PRODUCT
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.

CODE
Lots 290122001, 290122002, 290122003.

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

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

VOLUME OF PRODUCT IN COMMERCE
469,938 blister cards.

DISTRIBUTION
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.