Navigation Links
Endo Pharmaceuticals Issues Voluntary, Nationwide Recall of Two Lots of Endocet® (Oxycodone/Acetaminophen, USP) Tablets, 10 Mg /325 Mg
Date:6/24/2011

CHADDS FORD, Pa., June 24, 2011 /PRNewswire/ -- Endo Pharmaceuticals (Nasdaq: ENDP) today issued a voluntary nationwide consumer level recall of Endocet® (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg 100 count bottles, NDC 60951-712-70, Lot # 402415NV and #402426NV. One bottle from each lot of Endocet® (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg, Lot # 402415NV and # 402426NV, NDC 60951-712-70, 100 count bottles, was found to contain some Endocet® 10 mg/650 mg Tablets, which are identifiable by their larger size, and different shape and markings. Currently, no other bottles from the subject lots or any other lots have been found to erroneously contain Endocet® 10 mg/650 mg Tablets.

No injuries have been reported to date.

Because the recalled bottles may contain incorrect tablets that have a higher dosage of acetaminophen, consumers may take more than the intended acetaminophen dose.  Unintentional administration of tablets with increased acetaminophen content may result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day.   The product label warns consumers that acetaminophen overdosage can potentially cause severe liver damage.

Consumers who have the affected product should stop using the product and contact Endo's agent Stericycle at 1-866-723-2681 for return of the product.  If consumers have any questions as to whether they possess the affected product, please call the number listed above.

The recall includes the following lots of this product:

  • 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

This voluntary recall is being made with the knowledge of the U.S. Food and Drug Administration.

These lots were distributed between April 19, 2011 and May 10, 2011 directly to wholesalers who are located in the following states: AL, AZ, CA, CO, NY, OH, ND, PR, IL, KY, NH, NJ, LA, NC, MO, PA, FL and TN. These wholesalers may further distribute to other retailers and wholesalers nationwide.  Lot numbers can be found on the side of the manufacturer's bottle.  

Endocet® (oxycodone/acetaminophen, USP) 10 mg/325 mg tablets are 0.6 inches in length, 0.27 inches in width and yellow capsule-shaped tablets, marked "E712" on one side and "10/325" on the other.  By contrast, Endocet® (oxycodone/acetaminophen, USP) 10 mg/650 mg tablets are larger (0.7 inches in length, 0.4 inches in width) and yellow oval-shaped tablets, marked "E797" on one side and "10" on the other.  

Endo is notifying all customers who may have received affected product and arranging for the return of any affected product.

Consumers with questions may contact Endo's agent Stericycle at 1-866-723-2681 during the hours of 8AM - 8PM EST Monday through Friday and 8AM - 5PM EST Saturday and Sunday. The phones will be staffed by Stericycle.

Adverse reactions or quality problems experienced with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either on line, by regular mail, or by fax.


Reports of adverse reactions or quality problems can also be reported to Endo Pharmaceuticals at 1-800-462-3636.

About Endo Pharmaceuticals

Endo Pharmaceuticals is a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics. Endo is redefining its position in the healthcare marketplace by anticipating and embracing the evolution of health decisions based on the need for high-quality and cost-effective care. We aim to be the premier partner to healthcare professionals and payment providers, delivering an innovative suite of complementary diagnostics, drugs, devices and clinical data to meet the needs of patients in areas such as pain, urology, oncology and endocrinology. For more information about Endo Pharmaceuticals, and its wholly owned subsidiaries American Medical Systems, Inc., HealthTronics, Inc. and Qualitest Pharmaceuticals, please visit http://www.endo.com/.


'/>"/>
SOURCE Endo Pharmaceuticals
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Drs. Ben Machielse Joins Omthera Pharmaceuticals, Inc. as Chief Operating Officer
2. FDA Accepts Endo Pharmaceuticals Complete Response for New Formulation of OPANA® ER
3. PD-Rx Pharmaceuticals Acquires Wilson Medicals EMR
4. Merriman Capital Announces Sponsorship of Radient Pharmaceuticals Corporation on OTCQX
5. CureFAKtor Pharmaceuticals Demonstrates that Novel Focal Adhesion Kinase (FAK) Inhibitors Decrease Pancreatic Cancer Tumor Blood Flow and Reduce Blood Vessel Density
6. MAP Pharmaceuticals to Present Data on LEVADEX® at the 15th Congress of the International Headache Society
7. Radient Pharmaceuticals Corporation Joins OTCQX
8. Vista Partners Initiates Coverage on ADVENTRX Pharmaceuticals, Inc.; Target Price $7.50
9. Cempra Pharmaceuticals to Present at the 2011 Wells Fargo Healthcare Conference
10. Alder Biopharmaceuticals to Receive $15 Million Milestone Payment from Bristol-Myers Squibb for Initiation of Phase 2b Clinical Trial in Rheumatoid Arthritis of ALD518/BMS-945429 Antibody Therapeutic Against IL-6
11. Ortho-McNeil-Janssen Pharmaceuticals, Inc. Voluntarily Recalls One Lot of RISPERDAL® Tablets and One Lot of Risperidone Tablets
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/2/2017)... The Rebound mobile app is poised to become ... tide of prescription drug addiction. The app empowers users to ... stepping down their dosage in a safe, controlled manner while ... the first 100,000 people to sign up will enjoy 3 ... ...
(Date:9/27/2017)...  Commended for their devotion to personalized service, SMP Pharmacy ... one in the South Florida Business Journal,s 50 Fastest-Growing Companies, ... list, the national specialty pharmacy has found its niche.  To ... soon be honored by SFBJ as the 2017 Power Leader ... to receive his award in October, Bardisa said of the ...
(Date:9/25/2017)... R.I. , Sept. 25, 2017  EpiVax, ... assessment, vaccine design, and immune-engineering today announced the ... on the development of personalized therapeutic cancer vaccines. ... has provided exclusive access to enabling technologies to ... Eng., MBA will lead EpiVax Oncology as Chief ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... ProVest ... the greater Dallas, Miami, and Raleigh regions, is organizing an extended charity drive ... rare and deadly chromosome abnormality. , After struggling since birth with several health ...
(Date:10/13/2017)... ... October 13, 2017 , ... The International Association of ... of excellence for the field of eating disorders, announces the opening of early ... in Orlando, Florida at the Omni Resort at ChampionsGate. , The ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Many families have ... many long-term care insurance companies have a waiver for care if the client has ... period, when the family pays for care, is often waived, so the benefits from ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented host, actor Rob Lowe, ... in a new episode of "Success Files," which is an award-winning educational program ... investigates each subject in-depth with passion and integrity. , Sciatica occurs when the ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... treating sleep apnea using cutting-edge Oventus O2Vent technology. As many as ... disorder characterized by frequent cessation in breathing. Oral appliances can offer significant relief ...
Breaking Medicine News(10 mins):