The contraceptive pill Introvale has been withdrawn on advice from the FDA due to a packaging mix-up. The mix-up could lead to women not being protected.
The drugs company Sandoz has issued a notification to consumers and health stores explaining that it is withdrawing 10 lots of its oral contraceptive pill, which goes under the name Introvale or Seasonale.
Introvale contains the active ingredients levonorgestrel and ethinyl estradiol in tablet form and it is a popular contraceptive. The company Sandoz are a division of the ‘big pharma’ corporation Novartis.
According to Injury Board, the error goes back for quite a long time, as the lots were distributed across the USA between January 2011 and May 2012. The company have notified the U.S. Food and Drug Administration (FDA), who issued a safety alert.
The reason for the recall of the pills is due to a packaging flaw, according to the Chicago Tribune. This came to light after a consumer noticed an error and issued a complaint. The user noticed that the white placebo tablets were mistakenly 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”).
With this type of contraceptive pill (a hormonal and non-hormonal extended-cycle oral contraceptive), each three-month blister card contains 84 peach-colored active tablets and seven white placebo tablets in 13 rows, each representing one week. The risk from the mix-up was that an unintended pregnancy could occur by women taking the wrong tablet.
If consumers find incorrect packaged pills, the FDA has asked that this be reported via their MedWatch service.