As notified via a report issued by the U.S. Food and Drug Administration (FDA), Actavis is recalling 26 lots. This equals a staggering 511,283 boxes. The pills are branded Lutera (active ingredients levonorgestrel/ethinyl estradiol).
The FDA’s Enforcement Report, according to Fierce Pharma, indicates that the pills contain an out-of-date product inset, meaning that the full information is not available to consumers. The pills were produced on behalf of Actavis by the contract pharmaceutical drug manufacturer Patheon. The recall is categorized by FDA as a ‘class III.’ This means that there is no risk to users; nonetheless, the error is likely to be expensive for Actavis given that all boxes will need to be repackaged with the correct instructions.
The recall comes a few weeks after Johnson & Johnson issued a recall notice for a batch of Ortho-Cept (actives desogestrel ethinyl/estradiol) tablets. The recall affected the Canadian market. These are a different type of birth control pill. This was due to the potency of the two active ingredients possibly not meeting specifications, resulting in the risk that the pills may not actually work leading to the possibility of unwanted pregnancies.
One of the biggest contraceptive pill recalls was in 2012, PharmaFile recounts. Here drugs giant Pfizer withdrew a million packages of the branded Lo/Ovral-28 (actives ethinyl estradiol and norgestrel) pills. Here there was a systematic failure to package the product correctly, resulting in packages containing either too many pills with the required active ingredient or insufficient quantities. Again the risk was in unwanted pregnancies.
Sometimes consumers take action in the event of mislabeled drugs. Drawing on a contraceptive pill example, in 2013 when generic drugmaker Apotex was forced to recall contraceptive pills from the market this led to forty-five women to raise a class-action lawsuit for $778.8 million.
