FDA says 5 years of Warner Chilcott's Ovcon BC pills suspect
In what appears to be another pregnancy risk to women taking birth control pills, the FDA has sent a warning letter to Warner Chilcott ($WCRX) saying that for 5 years the potency of its Ovcon pills has been in question.
The letter follows an inspection last summer of the company's manufacturing plant in Fajardo, Puerto Rico. The FDA says that from 2006 until a recall in June 2011, "7 of 9 lots of Ovcon (Norethindrone (NE) 1 mg and Ethinyl Estradiol (EE)) 50 mcg tablets, laced on stability, failed to meet the assay test specification for Ethinyl Estradiol (EE) at different stability testing intervals." Because of this situation, the pills may not last until the expiration date, the FDA says.
The company has told the FDA that it didn't take action because it believes that another test on stability condition was a more appropriate indicator. However, the FDA says Warner is required to see that a drug passes both tests. The company also has said new packaging should help, but the FDA letter says a batch in the new packaging also failed a test.
This disclosure comes shortly after Glenmark Generics recalled 7 lots of norgestimate and ethinyl estradiol tablets manufactured in India, because the pills are rotated 180 degrees in the card. That announcement came about a month after Pfizer ($PFE) recalled a million packages of Lo/Ovral-28 pills and their generic counterparts for a similar packaging mishap. That event already has attorneys trolling for clients. In both cases, it was a consumer who noticed that something was wrong with the packaging.
- check out the FDA warning letter