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:7/17/2017)... -- MedX Holdings, Inc., the manufacturer and global distributor of ... today announced the national roll out of its MedX ... standard for the treatment of low back injuries and ... How it works: MedX ... who prescribe the MedX Home Back Machine Program for ...
(Date:7/14/2017)... July 13, 2017 It should come as no ... is in the midst of a crippling opioid epidemic. ... 1999, the number of overdose deaths from opiate-based medications has ... half a million dead from 2001 to 2015". During this ... hydrocodone has similarly quadrupled, drawing a compelling link between prescription ...
(Date:7/13/2017)... Md. , July 13, 2017  New York City-based ... of pharmaceutical markets should be aware of.  From new products ... trends are detailed in a recently completed study, Potential ... 1.  Age-Driven Growth ... we have been aware of the impact the growing population ...
Breaking Medicine Technology:
(Date:7/21/2017)... ... July 21, 2017 , ... The ... consultations to communities in the greater Denver region, is announcing a charity drive ... a very rare kind of epilepsy. , Until a few months ago, Dominik ...
(Date:7/21/2017)... Grove, Ill. (PRWEB) , ... July 21, 2017 , ... ... & Fabric Liquid eco-friendly odor-control solution for colleges and universities at the ... safely and effectively eliminate severe cannabis and tobacco smoke odors without the use of ...
(Date:7/21/2017)... ... ... Pastor and Overseer at The House of Yahweh in Abilene, Texas, has written a new ... pleads with world leaders to be more open about positive changes. Yisrayl says the use ... is a peaceful and positive way to solve all; yes, all issues, and he is ...
(Date:7/21/2017)... , ... July 21, 2017 , ... West Dermatology is ... Doan Vu, PA-C. Beginning July 17, 2017, Ms. Vu will join West Dermatology’s large ... of experience in dermatology, skin cancer , and more. She graduated from the ...
(Date:7/20/2017)... Va. (PRWEB) , ... July 20, 2017 , ... ... McCarter, MD, has joined JenCare Senior Medical Center as Richmond Chief Medical ... Virginia School of Medicine, and Associate Chief Medical Officer of Ambulatory Services for the ...
Breaking Medicine News(10 mins):