Company: Warner Chilcott
Plant: Fajardo, Puerto Rico
Warning letter: March 8, 2012
Amid a spate of reports of recalls of birth control pills, primarily because of packaging problems, the Ireland-based Warner Chilcott got a warning letter saying that failed assay tests puts the potency of 5 years-worth its Ovcon birth control pills into question. The agency noted 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, placed on stability, failed to meet the assay test specification for Ethinyl Estradiol (EE) at different stability testing intervals." Because of failures, the pills may not last until the expiration date, the FDA says. When the company responded that it didn't take action because it believes that another test on stability condition was a more appropriate indicator, the FDA told Warner the pills need to pass both tests to assure strength.
Aside from what the report suggests about the importance of stability testing, the warning letter was posted about the same time that the public was getting a big dose of news on problems with birth control. In particular, Pfizer ($PFE) recalled a million packages of Lo/Ovral-28 pills and their generic counterparts because some packages had the active ingredient and placebo pills out of order. Shortly thereafter, Glenmark Generics initiated a recall of some of its pills for a similar reason.