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Introvale® Packaging Flaw Recall

For years, birth control pills have been a reliable way for women to prevent pregnancy. With simple instructions and easy, problem-free packaging that lets users keep track of the contraceptives each day, these products are virtually flawless. But, what happens when one of the most dependable birth control manufacturers makes an error in the packaging of these trusty pills?

13-week blister card proper Introvale® packaging

Introvale®, one of the latest contraceptives manufactured by Sandoz, stands face-to-face with this problem. Introvale® is the generic brand and equivalent of Seasonale® as a levonorgestrel and ethinyl estradiol combination to prevent pregnancy. Typically, the box of birth control pills comes in a blister card including several rows of tablets to be taken each week. According to the U.S. Food and Drug Administration, each card comes with 84 peach-colored active pills and one week worth of white placebo pills placed in the 13th row to be taken on the 13th week (as shown to the right).

However, an issue came to the the company’s attention as one consumer pointed out that the birth control pills in the box were out of order. In packages containing the error, the placebo tablets were found in the “9th week” row instead of the “13th week”. The flaw may be easy to recognize due to the distinct color differentiation between the tablets, but this does not override the fact that many consumers may not have noticed the misplacement. In these cases, women taking the pills in the wrong order have a definite increased possibility of becoming pregnant.

As of June 5, Sandoz has announced to the U.S. Food and Drug Administration that they will be recalling a total of 10 lots of their latest contraceptive, Introvale®. If you have taken or are taking  Introvale®, check to make sure your packaging is correct.

Lot numbers included in the recall for this medication are: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C. Distributions involved were between January 2011 and May 2012 and only made in the United States. If you have received a flawed package, Sandoz asks that you immediately begin using a “non-hormonal form of birth control”and contact Sandoz Drug Information Direct Line by calling 800-525-2492 or by emailing [email protected].

This is the 4th major recall due to contraceptive packaging errors, and the 3rd recall in this past year alone. If you are taking birth control pills, make sure to check for proper placement of the tablets in the package and read all instructions to avoid the risk of unwanted pregnancy.