Introvale Birth Control Pill Recall Due To Risk of Unintended Pregnancy

Ten lots of Introvale birth control pills were recalled from stores this week, after it was discovered that a flaw in the packaging process may expose users to a risk of unwanted pregnancy.

The Introvale birth control pill recall was announced by the FDA and the manufacturer, Sandoz, on June 5, after a consumer found placebo pills in the wrong row.

Sandoz indicates there is little likelihood that users would take the pills out of order, because the placebo pills are white and the pills with active ingredients, levonorgestrel and ethinyl estradiol, are peach. However, taking the wrong pill “cannot be excluded,” which may leave women exposed to a risk of pregnancy.

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The recalled birth control pills are packaged in three-month blisters, with each three-month blister card containing 84 peach-colored active tablets and seven white placebo tablets arranged in 13 rows. Each row contains seven pills, representing one week. The consumer reported that one row of white placebo pills were in the ninth row instead of in the 13th row where they should be.

The recall affects 10 lots of Introvale extended cycle oral contraceptive pills. The recalled pills were distributed in the United States between January 2011 and May 2012 and have the following lot numbers: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C.

This is at least the fourth birth control recall issued this in less than a year due to incorrect packaging and labeling of pills, which may expose users to a risk of unintended pregnancy. The most recent occurred in February, when Glenmark Generics issued a norgestimate and ethinyl estradiol recall, also due to packaging issues.

In January, Pfizer recalled about one million packs of Lo/orval-28 and generic norgestrel birth control pills due to similar problems, where some blister packs in 28 different lots were identified as potentially containing the wrong number of pills and out of sequence tablets.

A Qualitest birth control pill recall was issued in September 2011, impacting 70 lots Cyclafern, Emoquette, Gildess, Orsythia, Previfem and Tri-Previfem pills, which also contained blister packages that may have been rotated 180 degrees during packaging, reversing the weekly tablet orientation.

Sandoz recommends that women who find their pills out of order should stop using them, switch to a non-hormonal form of birth control, and contact Sandoz by calling (800) 525-2492 or by sending the company an email at qa.druginfo@sandoz.com.

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