Sandoz voluntarily recalls 10 lots of Introvale birth control pills

A 13-week blister package of Introvale birth control pills is displayed with the placebo pills in the right place. FDA

A 13-week blister package of Introvale birth control pills is displayed with the placebo pills in the correct order.
FDA
(CBS News) Sandoz, a subsidiary of pharmaceutical company Novartis, is voluntarily recalling 10 lots of its generic Introvale birth control due to an incorrectly placed placebo pills.

The U.S. Food and Drug Administration said that each three-month blister card contains 84 peach-colored active tablets and 7 white placebo tablets. In the packs with the error, the placebo tablets are placed in the 9th week slot instead of the correct 13th week slot. The picture on the left shows the correct order of pills.

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"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 the FDA statement.

The lot numbers in question were distributed in the U.S. between January 2011 and May 2012. Their numbers are: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C.

Sandoz suggested that if a pill-taker finds that the placebos are placed in the wrong week, they should immediately discontinue using the tablets and switch to a non-hormonal form of birth control. They recommended that the person call their health service provider immediately, and call or email the Sandoz Drug Information Direct Line at 800-525-2492 or qa.druginfo@sandoz.com to report the error. The company said, however, that there have not been any adverse reactions because of the packaging problem, but the recall is being done as a precautionary matter.

This marks the fourth major birth control pill recall in recent news. HealthPop previously reported that in February, Pfizer recalled 1 million birth control packages because the pills were either in the wrong spot or had the wrong number of the different pill kids in each blister. Qualitest Pharmaceutical also had a recall because they placed pills in the wrong places inside their packages in February. An Indian-based company, Glenmark Generics, also recalled its pills in February because the pills were in the wrong order.

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