Women sue Endo for packaging mix-up ‘that left 113 pregnant’

By Fiona BARRY contact

- Last updated on GMT

A packing mistake mislabelled 'placebo week' pills as active
A packing mistake mislabelled 'placebo week' pills as active

Related tags: Combined oral contraceptive pill

More than one hundred women are suing a subsidiary of Irish manufacturer Endo International, claiming a packaging error caused their contraception to fail and result in unwanted pregnancies.

Qualitest Inc., a QA company owned by manufacturer Endo International, is named in the suit as well as generics maker Vintage Pharmaceuticals, and the contract manufacturing organisation Patheon, according to Philadelphia localnews.

A class-action suit was rejected by a judge in Georgia last week and filed instead in the Philadelphia Court of Common Pleas.

The 117 individuals say all but four of them became pregnant as a result of a packaging error with their oral contraception in 2011. 94 of the women went on to give birth.

Mislabelled placebos

The FDA said the blister packs “were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date no longer visible. This packaging error and the potential for this error to have affected other oral contraceptive products resulted in the company issuing the recall of multiple lots.​”

The defect meant patients were directed to take inactive pills during a week when they should have been taking hormonal contraception.
Qualitest was forced to recall Cyclafem 1/35, Cyclafem 7/7/7, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20, Orsythia, Previfem, and Tri-Previfem.

Responding to news of the lawsuit, Endo commented, "Our commitment is to patient safety and we take product quality very seriously. [...] There is no new or recent product recall,​” reported a US TV station.

The recall that forms the basis of this suit was entirely voluntary and occurred more than four years ago in September 2011. The voluntary recall occurred based on an extremely small number of pill packs that were manufactured by an external contract manufacturer.

“Endo has been able to confirm only one blister pack that manifested a defect and was sold to a patient. Additionally, courts have dismissed cases arising out of the recall because the plaintiff could not establish that she purchased a defective package.​"

In 2012, Pfizer recalled batches of its oral contraceptives​ after a similar packaging error.

Related topics: Processing, QA/QC

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