Some bottles of Endocet, a painkiller combining the active ingredients of OxyContin and Tylenol, have been found to contain pills with the wrong dose, resulting in two lots of the pills being removed from the market.
The Endocet recall was announced on June 24 by the FDA after bottles were discovered containing pills with much more powerful doses of acetaminophen, the active ingredient in Tylenol, than was listed on the bottle. The pills are larger in size and have different shapes and markings.
The bottles are supposed to contain Endocet tablets containing 10mg of oxycodone (OxyContin’s active ingredient) and 325mg of acetaminophen. However, some tablets found in the bottles had 650mg of acetaminophen instead.
The recall affects 100 count bottles of Endocet 10mg/325mg tablets with lot numbers 402415NV and 402426NV. Both have an NDC of 60951-712-70 and an expiration date of 01/2014. The affected bottles were distributed to Arizona, California, Colorado, New York, Ohio, North Dakota, Illinois, Kentucky, New Hampshire, New Jersey, Louisiana, North Carolina, Missouri, Pennsylvania, Florida, Tennessee and Puerto Rico between April 19 and May 10 of this year.
The correct pills are yellow capsule-shaped tablets marked E712 on one side and 10/325 on the other side. They are 0.6 inches long and 0.27 inches wide. The incorrect pills are yellow oval-shaped tablets marked E797 on one side and 10 on the other. They are 0.7 inches long and 0.4 inches wide.
The manufacturer, Endo Pharmaceuticals, says it is in the process of notifying all customers who may have received the recalled pills to arrange for their return. Consumers who have Endocet bottles affected by the recall should stop using the pills and contact Stericycle at 1-866-723-2681 to arrange to return the pills for a full refund.
Acetaminophen, the generic name for Tylenol, is a pain killer and anti-inflammatory medication found in a number of over-the-counter and prescription drugs. In recent years, federal regulators have become concerned over the frequency of its use in a variety of medications. Overuse of the drug could increase the risk of liver injury and other health problems, according to the FDA.
Earlier this year the FDA placed new limits on acetaminphen’s use in other, more powerful, painkillers. Drugs affected by the new acetaminophen limits include Vicodin (acetaminophen and hydrocodone), Percocet (acetaminophen and oxycodone), and Tylenol with Codeine (acetaminophen and codeine).