August 20, 2003
Barr Laboratories Has Recalled Nortrel
7/7/7 Oral Contraceptive Tablets
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,
VOLUME OF PRODUCT IN COMMERCE
469,938 blister cards.
Nationwide, and Puerto Rico.