Oxycodone / Acetaminophen Tablets (Endocet)
June 27, 2011
Endo Pharmaceuticals is voluntarily recalling 2 lots of oxycodone 10 mg / acetaminophen 325 mg (Endocet 10 mg / 325 mg) in 100-count bottles (NDC 60951-0712-70; lot numbers 402415NV and 402426NV). Two bottles labeled as oxycodone 10 mg / acetaminophen 325 mg contained several tablets of oxycodone 10 mg / acetaminophen 650 mg. Both of the recalled lots are at risk for similar errors. Recalled lots were distributed to wholesalers throughout the country between April 19, 2011 and May 10, 2011.
No injuries have been reported. However, use of a different product strength could result in serious side effects due to unintentional ingestion of higher doses of acetaminophen. Inadvertent ingestion of higher acetaminophen doses may cause liver damage in certain individuals. Consumers at increased risk of liver damage include patients with preexisting liver disease, those who consume more than 3 alcoholic beverages per day, and those who are taking other products containing acetaminophen.
Consumers should stop using product from the affected lots. All consumers with Oxycodone / Acetaminophen manufactured by Endo in their possession are encouraged to check the identity of the tablets, against the following descriptions:
- Oxycodone 10 mg / acetaminophen 325 mg tablets (Endocet 10 mg / 325 mg): yellow, capsule-shaped tablets, approximately 0.6 inches long and 0.27 inches wide. The imprint reads “E712” on one side and “10/325” on the reverse side.
- Oxycodone 10 mg / acetaminophen 650 mg tablets (Endocet 10 mg / 650 mg): yellow, oval-shaped tablets, approximately 0.7 inches long and 0.4 inches wide. The imprint reads “E797” on one side and “10” on the reverse side.
Contact Endo’s agent, Stericycle, at 1-866-723-2681, weekdays from 8AM to 8PM Eastern Standard Time and Saturdays from 8AM to 5PM EST, for reimbursement information or for answers to other recall-related questions. Report any quality concerns or adverse events associated with the affected product to the MedWatch program. Additional information is available at the following links:
- MedWatch Alert:
- Company Press Release:
June 27, 2011; University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.