Packaging Flaw Prompts Contraceptive Recall

Placebo Tablets Misplaced in Introvale Blister Card

June 12, 2012 02:25 pm News Staff

This representative Introvale blister card shows the proper placement of the white placebo tabletst.

According to a June 6 FDA drug safety communication(www.fda.gov), Sandoz Pharmaceuticals is voluntarily recalling 10 lots of its generic levonorgestrel and ethinyl estradiol tablets, sold as Introvale, after a consumer reported a product packaging flaw.

Each three-month Introvale card is supposed to contain 84 peach-colored active tablets in 12 seven-dose rows and seven white placebo tablets in the 13th and final row. In the mispackaged cards, the white placebo tablets were mistakenly placed in the "Week 9" row of the blister card instead of the "Week 13" row.

If the pills are taken in the wrong order, the risk of unintended pregnancy "cannot be excluded," said the FDA alert.

The lot numbers involved in the recall -- LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C -- were distributed in the United States between January 2011 and May 2012.

According to a June 5 Sandoz release(www.fda.gov), the probability of the packaging flaw causing serious adverse health consequences is remote, and the company is not aware of any reports of related adverse events.

The FDA recommends that any patient taking Introvale who finds one of the white placebo tablets in any row of the blister pack other than the 13th row should immediately begin using a nonhormonal form of contraception and contact her health care professional. Adverse events that may be related to the use of these products can be reported to MedWatch(www.fda.gov), the FDA's safety information and adverse event reporting program.


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