Endocet bottles recalled for incorrect dosage

Consumer Reports News: June 27, 2011 02:53 PM

The U.S. Food and Drug Administration and Endo Pharmaceuticals have issued a nationwide recall of bottles of Endocet. The problem: The bottle may contain tablets with higher concentrations of acetaminophen than indicated on the label, which could lead to health complications.

The recall affects bottles labeled "Endocet® (oxycodone/acetaminophen, USP) Tablets, 10 mg /325 mg 100 count" with an expiration date of January 2014 and a Lot number of either 402415NV or 402426NV. Some of these bottles may contain the larger Endocet tablets (see image) which have higher oxycodone/acetaminophen ratios of 10mg/650mg.

The flawed Endocet bottles were distributed between April and May to wholesalers in 18 states, including California, Florida, New York and Ohio. The affected bottles may have been further distributed to other wholesale and retail outlets, hence the nationwide recall by the FDA and manufacturer.

Although no injuries have been reported so far, the FDA warns that increased acetaminophen consumption could lead to liver damage, especially in patients already suffering from liver disease or those who consumer more than three alcoholic beverages per day.

Consumers who have the recalled bottles of Endocet are warned to stop taking the medication and contact Endo Pharmaceuticals' agent, Stericycle (866-723-2681), for instructions on returning the product.

To report any adverse reactions with the drug, consumers can visit the FDA's website (www.fda.gov/medwatch/report.htm) or call Endo's toll-free telephone line: 800-462-3636.

For more information about Endocet, visit Consumer Reports on Health and its online guide of Best Buy Drugs.

Endo Pharmaceuticals Issues Voluntary, Nationwide Recall of Two Lots of Endocet [FDA]

—Paul Eng