Packaging Flaw Leads to Recall of Contraceptives

introvale

 

(June 10, 2012) – The U.S. Food and Drug Administration (FDA) notified healthcare professionals about a voluntary manufacturer recall of their contraceptive levonorgestrel and ethinyl estradiol tables (Introvale, Sandoz) due to a packaging flaw which could very well result in unplanned pregnancy.

 

The manufacturer, Sandoz, notified the public that is was issuing a voluntary recall of ten lots of its generic oral contraceptive, which was circulating in the United States following a recent report of a packaging flaw.

 

The following lot numbers in the recall, which were distributed between January 2011 the May 2012 (only in the U.S.) are:   LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C, and LF01262C.

 

Each of the recalled ten lots contains approximately 4300 units. According to the head of global medial relations for Sandoz, Maria Mandic, only about 1 percent of the affected lot has been distributed to the market, or 48 units. “Across the ten lots, there were approximately 31,800 units distributed between January 2011 and May 2012 with an estimated 3700 units remaining in distribution channels (unused),” Mandic said.

 

“Each unit consists of three 3-month cards,” she told Medscape Medical News. “Those units that have been distributed have been on the market for nearly 2 months. This is the only reported complaint for the lot, and we have not received any related adverse event reports, and the remaining 4245 units of the impacted lot have not been distributed,” she said.

 

The way this was discovered was a consumer reported that the white placebo tablets were mistakenly placed in the ninth row (labeled “Week 9”) of the 13-row blister card, rather than in the correct position in the 13th and final row (labeled “Week 13”).  Each 3-month blister card contains 84 peach-colored active tablets and seven white placebo tablets in 13 rows, each representing one week.

 

The purpose of having different colored pills in each packet is to distinguish them from one another. While the white placebo tablets can be easily identified from the peach-colored active tablets, the risk of an unintended pregnancy in a patient who takes the wrong tablet over a period of a few days cannot be excluded.

 

The FDA recommends that if a patient finds a white placebo tablet in any position other than the 13th and final row (Week 13), she should immediately begin using a non-hormonal form of contraception and contact her healthcare professional.

 

It is important to be aware of the medications you take. You should be familiar with the color of your contraceptive and which day you are supposed to take which pill. If you are not cognizant of what you put into your body, you may wind up taking the wrong medicine, or even discover that you are pregnant.

 

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