Navigation Links
Qualitest Issues Voluntary, Nationwide Recall for One Lot of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg Due to the Potential for Oversized Tablets
Date:9/10/2012

HUNTSVILLE, Ala., Sept. 10, 2012 /PRNewswire/ -- Qualitest, a subsidiary of Endo Health Solutions (Nasdaq: ENDP), today issued a voluntary, nationwide retail level recall for one lot of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg.

The recall includes the following product lot:

- Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg, NDC 0603-3888-21, 100 count, Lot Number C1440512A, expiry date 12/13.

It is possible that some tablets from lot C1440512A exceed the weight specification and could be super-potent for the ingredients Hydrocodone Bitartrate and Acetaminophen.

Bottles from the affected lot may contain tablets that have a higher dosage of acetaminophen, and as a result, it is possible that consumers could take more than the intended acetaminophen dose.  Unintentional administration of tablets with increased acetaminophen content could 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 overdose can potentially cause severe liver damage, at times resulting in liver transplant or death.  Taking a higher dose of hydrocodone than intended could result in an increase in the severity or frequency of side effects, such as sedation or respiratory depression, particularly in patients who are elderly, have severe kidney or liver impairment, or are also taking interacting medications, for example other sedating medications or certain antidepressants.

No injuries have been reported to date.

Hydrocodone bitartrate and acetaminophen 10 mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain.  The affected lot, C1440512A, was distributed between May 14 and Aug. 3, 2012 to wholesale distributors and retail pharmacies nationwide.  The lot number can be found on the side of the manufacturer's bottle.  Hydrocodone Bitartrate and Acetaminophen Tablets are approximately 16.51 mm in length, pink, capsule-shaped tablets, with "3600" debossed on one side of the tablet and "V" on the other. 

Consumers who have lot C1440512A should contact Qualitest at 1-800-444-4011.  Consumers who are unsure if they have the affected lot number should consult their pharmacy or health care professional. 

Pharmacists and wholesalers are asked to check their inventories for lot C1440512A, segregate any material from the lot, and to contact MedTurn at 1-800-967-5952 for instructions on product return.  Pharmacies that received lot C1440512A will receive a copy of this press release with their recall notification information. In order to make your patients aware of this recall, please post the enclosed press release prominently in the pharmacy area.

For more information please contact Qualitest at 1-800-444-4011; Monday through Friday between the hours of 8 a.m. and 5 p.m. CST.  Reports of adverse reactions or quality problems can also be reported to Qualitest at 1-800-444-4011; Monday through Friday between the hours of 8 a.m. and 5 p.m. CST.

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.

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

About Qualitest

Founded in 1983, Qualitest provides affordable, high-quality generic pharmaceuticals. Featuring a current portfolio exceeding 600 products, the company has grown significantly since its inception and is now ranked in the top ten among all suppliers of generics, based on total prescriptions filled. Qualitest is a wholly owned subsidiary of Endo Health Solutions (Nasdaq: ENDP), a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics (www.endo.com). 


'/>"/>
SOURCE Qualitest
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Qualitest Receives FDA Approval for Levetiracetam Extended-Release Tablets, 500mg and 750mg
2. Icahn Issues Statement Regarding Amylin Pharmaceuticals
3. Patient Advocate Foundation Announces New Co-Pay Relief (CPR) Offerings for Patients Facing Health Issues Due to Electrolyte Imbalance
4. U.S. Patent Office Issues Sixth Patent Covering Zero-Footprint Medical Image Viewers to Heart Imaging Technologies, LLC
5. Upcoming Presentations on Global Market Access Issues and Trends in Health Economics and Outcomes Research at ISPOR 2012 by Novel Health Strategies
6. BD Issues 2011 Sustainability Report
7. Ameritox Announces Educational Resources to Help Physicians Navigate Complex Compliance Issues
8. OncoSec Medical Issues Letter to Shareholders
9. FDA Issues Complete Response Letter for 800mg PREZISTA® (darunavir) Tablet
10. PAREXEL International Issues Earnings Guidance In Conjunction With Investor Day
11. MLB All-Star Pitcher CC Sabathia Issues Fast Relief Challenge to Generate Donations for the American Red Cross
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... 2, 2016 Quantum Radiology,s Mobile Breast Center ... interpretation directly to women at the workplace, thereby maximizing ... as Delta Air Lines and SunTrust Bank, and community ... component of wellness initiatives. "I think it,s ... enables them to have a mammogram without taking a ...
(Date:12/2/2016)... ALEXANDRIA, Va. , Dec. 2, 2016 /PRNewswire-USNewswire/ ... year by the Academy of Managed Care Pharmacy ... care organizations can better address the opioid addiction ... Medication Assisted Therapies (MAT). ATAG,s newly ... in Improving Access to Naloxone," addresses many issues ...
(Date:12/2/2016)... 2, 2016 CVS Health Corporation (NYSE: ... in New York City on Thursday, December 15, 2016, beginning at 8:00 a.m. ... will provide an in-depth review of the company,s strategies ... company will also discuss 2017 earnings guidance during the ... the event will be broadcast simultaneously on the Investor ...
Breaking Medicine Technology:
(Date:12/5/2016)... (PRWEB) , ... December 05, 2016 , ... ... announces today that they have teamed up with The American College of Surgeons ... the ACS’s Committee on Trauma, the “Bleeding Control Basic” course is a pilot ...
(Date:12/4/2016)... Fl (PRWEB) , ... December 02, 2016 , ... ... that will give patients better access to nutraceuticals and help doctors more efficiently ... EMR patient portal and practice management software platform for Integrative and Functional Medicine. ...
(Date:12/4/2016)... ... December 03, 2016 , ... ... transitions and many more tools allowing FCPX editors to create professional looking video ... Studios. , Perfect Harmony contains a beautifully designed 3D environment for placing ...
(Date:12/4/2016)... ... December 03, 2016 , ... ... at the 2016 Anti-Aging & Beauty Awards at The Aesthetic & ... & Anti-Aging Medicine European Congress (AMEC) brings together the industry’s leading scientific ...
(Date:12/4/2016)... (PRWEB) , ... December 04, 2016 , ... ... presets that have new attractive animation styles with unique displacement design elements," said ... 30 pre-animated lower third designs. Choose from a variety of design styles that ...
Breaking Medicine News(10 mins):