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7/10/2003

Barr Labs Recalls Oral Contraceptive Tablets

Kate Traynor

Barr Laboratories yesterday announced a recall of three lots of Nortrel 7/7/7 28-day oral contraceptive pack containing norethindrone and ethinyl estradiol tablets.

The company stated that in two known instances, 28-day blister cards of Nortrel had the color-coded tablets in the wrong sequence. According to a company statement, placebo tablets were in the first row on the card instead of the last row. Taking the tablets in the order specified on that card could increase a woman's chance of becoming pregnant.

The affected lots of Nortrel are 290122001, 290122002, and 290122003. Also subject to the recall are blister cards on which no lot number appears on the upper right-hand corner of the package.

Barr asked women who have purchased Nortrel to carefully check their blister cards and to return those with out-of-sequence tablets to their pharmacy for a replacement. The company cautioned women who have begun to take out-of-sequence tablets—or who think they might have done so—to continue taking the product and to contact their health care provider for instructions.

Blister cards with properly packaged tablets contain four rows of seven tablets each. Tablets are yellow on the top row, blue on the second row, and peach on the third row. White placebo tablets are packaged on the bottom row.

Barr will pay for pregnancy testing of any woman who purchased and used tablets from a blister card with out-of sequence tablets.

The company described the mispackaging as "an isolated incident limited to the lots in question." Additional information about the recall is available by telephone from Barr's Drug Information service at 800-222-0190, ext. 33302.