FDA Issues Warning Letter to Warner Chilcott, PLC Suggesting Subpotent Birth Control Pills Problem
Published: Mar 14, 2012
Yet another problem for Warner Chilcott. Last month, the drugmaker disclosed that the feds issued a subpoena for information on a wide array of sales and marketing activities (see here). Now, the FDA has issued a warning letter suggesting quality problems have existed for the past five years with the Ovcon birth control pill. The letter was prompted by an inspection last June of a Warner Chilcott plant in Puerto Rico. And the FDA notes the drugmaker did not thoroughly investigate identify the reason that certain lots of Ovcon failed stability testing going back to 2006. This can cause a problem with expiration dates. Meanwhile, Warner Chilcott continued to make Ovcon 50 tablets, even though these may have been subpotent.