More than 100 women who thought they were protected from pregnancy by their birth control pills have filed a lawsuit against a manufacturer because the pills were packaged incorrectly.
Court documents suggest the women took the pills as directed, but they failed to work because of a packaging error. The package was rotated 180 degrees, reversing the orientation of the pills -- meaning that women took placebo pills when they should have been taking active pills.
The pills were manufactured by Qualitest Pharmaceuticals, a subsidiary of Endo Pharmaceuticals. The company voluntarily recalled the lots of pills in September 2011, according to the FDA.
Court documents filed in April suggest that the company distributed a "dangerous" and "defective" product, but the recall notice posted on the FDA website said the packaging issue didn't "pose any immediate health risks."
A spokeswoman for Endo Pharmaceuticals said the company is aware of the complaint, but does not comment on pending or ongoing litigation. In a statement, she noted there is no new or recent product recall, and emphasized that "patient safety is our top priority."
The recall was based on "an extremely small number of pill packs that were manufactured by an external contract manufacturer," spokeswoman Heather Zoumas Lubeski said. "Endo has been able to confirm only one blister pack that manifested a defect and was sold to a patient."