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Introvale birth control pills recalled because packaging error may lead to unintended pregnancy

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Women taking the oral contraceptive Introvale® should be advised that the manufacturer is recalling certain lots of the product because a packaging error could reduce the effectiveness.

Sandoz, a division of Novartis group, announced it is recalling ten lots of Introvale in the United States after a consumer reported that the white placebo tablets were in the wrong row of the blister pack she received.

Introvale (levonorgestrel and ethinyl estradiol tablets) is the generic alternative to Seasonale brand oral contraceptive. It is an extended-cycle oral contraceptive intended for use over the course of thirteen weeks and packaged in a blister pack containing 84 (Week 1-12) of active ingredient peach colored tablets and 7 (Week 13) white inert tablets. The consumer reported that the white inert tablets were in the row labeled “Week 9” instead of in the correct position of “Week 13.”

“While the white placebo tablets can be clearly distinguished from the peach-colored active tablets, the risk of an unintended pregnancy for a patient taking the wrong tablet over several days cannot be excluded,” Sandoz said in a news release. “In the unlikely event that a patient finds a white placebo tablet in any position other than the 13th and final row (Week 13), they should immediately begin using a non-hormonal form of contraception.”

The manufacturer distributed the product lots between January 2011 and May 2012. Introvale lot numbers recalled include LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C.

Women who find their Introvale product contains a packaging error should contact their healthcare professional as well as Sandoz to report the finding via the Sandoz Drug Information Direct Line at 800-525-2492 or via email at qa.druginfo@sandoz.com.

The U.S. Food and Drug Administration (FDA) is also asking consumers and healthcare professionals to report adverse events, side effects or quality problems with this product to the FDA’s MedWatch program.