FDA Warns Warner over Ovcon Birth Control Effectivness

Washington, DC: The Food and Drug Administration (FDA) has sent a warning letter to Warner Chilcott stating that the potency of its Ovcon birth control pills has been questionable for the past 5 years, posing the risk of possible pregnancy to women taking the pills.

The FDA letter results from, among other things, an inspection undertaken last summer at Warner's manufacturing plant in Fajardo, Puerto Rico. The FDA says that from 2006 until a recall in June 2011, "7 of 9 lots of Ovcon (Norethindrone (NE) 1 mg and Ethinyl Estradiol (EE)) 50 mcg tablets, laced on stability, failed to meet the assay test specification for Ethinyl Estradiol (EE) at different stability testing intervals." Because of this situation, the pills may not last until the expiration date, the FDA says. The FDA letter states "We are concerned that the current stability data does not support your labeled expiration date." And, testing of Ovcon in newly released packaging has also shown failure in the stability test.

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Published on Mar-13-12