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Warner Chilcott Warned over OvCon Birth Control Pills

Filed March 15th, 2012 Laurie

The Food and Drug Administration recently sent a letter to Warner Chilcott informing them that the potency of their Ovcon birth control pills have been subject to scrutiny for the past five years. After an inspection at the company’s manufacturing plant in Fajardo, Puerto Rico, the FDA said from 2006 until a recall last summer, “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.” The agency said for that reason, the pills’ potency may not last as long as the expiration date.

Warner Chilcott told the agency it had opted not to take action because it believes another test on stability condition was a more accurate test. According to the FDA, the drug must pass both tests, not just one, and in the letter the agency a batch in the new packaging also failed a test, even after the company said new packaging would help.

The letter comes just as Glenmark Generics recalled 7 lots of norgestimate and ethinyl estradiol tablets manufactured in India, because the pills are rotated 180 degrees in the card, which would cause women to take them in the wrong order. And a month prior to that, Pfizer recalled a million packages of Lo/Ovral-28 pills and their generic counterparts because of their own packaging problem.

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