Recalls

FDA recalls two lots of painkiller Endocet

Specific lots of Endocet, a prescription painkiller that combines the drugs oxycodone and acetaminophen, are being recalled by the drug company Endo Pharmaceuticals because some bottles may contain different strength tablets, which could cause serious health problems in consumers, according to the Food and Drug Administration (FDA).

Oxycodone is in a group of medications called narcotic pain relievers. Acetaminophen is a less potent pain reliever that increases the effects of oxycodone. The drug is primarily used to relieve moderate to severe pain.

Unintentional administration of tablets with increased actaminophen content may result in liver toxicity, especially in patients on other acetaminophen-containing medications, patients with liver dysfunction, or people who consume more than three alcoholic beverages a day.

The recall involves the following lots:

  • Endocet® (oxycodone/acetaminophen, USP) Tablets, 10 mg /325 mg 100 count bottles, NDC 60951-712-70, Lot # 402415NV, Expiry 01/2014; and
  • Endocet® (oxycodone/acetaminophen, USP) Tablets, 10 mg /325 mg 100 count bottles, NDC 60951-712-70,Lot # 402426NV, Expiry 01/2014

The recalled Endocet bottles were distributed between April 19, 2011 and May 10, 2011 directly to wholesalers located in the following states: Alabama, Arizona, Colorado, New York, Ohio, North Dakota, Illinois, Kentucky, New Hampshire, New Jersey, Louisiana, North Carolina, Missouri, Pennsylvania, Florida and Tennessee. The wholesalers may have further distributed the drugs to other retailers and wholesalers nationwide.

Consumers who have experienced any problems with Endocet should contact their doctors. They may call Endo’s agent Stericyle at 1-866-723-2681, with any questions about the recall.

Any side effects with this or any other drug should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA