Navigation Links
Qualitest Issues Voluntary, Nationwide Recall of 101 Lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg Due to the Potential for Oversized Tablets
Date:12/6/2012

HUNTSVILLE, Ala., Dec. 6, 2012 /PRNewswire/ -- Qualitest, a subsidiary of Endo Health Solutions, (Nasdaq: ENDP) today issued a voluntary nationwide recall for 101 lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg. This includes product with the following NDC numbers and lot numbers beginning with the letter "C". NDC Number

Bottle Count0603-3888-16

300603-3888-20

600603-3888-02

900603-3888-21

1000603-3888-22

1200603-3888-26

1500603-3888-04

1800603-3888-28

5000603-3888-32

1000It is possible that a number of tablets from the affected lots may exceed the weight requirement and could exceed the label claim potency requirements for the ingredients of  hydrocodone bitartrate and acetaminophen. Hydrocodone bitartrate and acetaminophen 10mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain. 

Bottles from the affected lots 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.

The affected lots, were distributed between Feb. 20, 2012 and Nov. 19, 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.It is very important that consumers do not exceed the maximum daily dose in the prescribing information for this product (no more than 6 tablets per day) and are fully aware of any other prescription or over-the-counter medications they may be taking that contain acetaminophen. If there is any doubt, a consumer should consult with their health care professional.

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.

Consumers who have the affected lots should contact Qualitest at 1-800-444-4011.  Consumers who are unsure if they have the affected lot numbers or have any concerns about their product should consult their pharmacy or health care professional. 

Pharmacists and wholesalers are asked to check their inventories for the affected lots, segregate any material from the lots, and to contact MedTurn at 1-800-967-5952 for instructions on product return.  Pharmacies that received the affected lots will receive a copy of this press release with their recall notification information to be prominently posted 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.

  • Online: www.fda.gov/medwatch/report.htm
  • Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
  • Fax: 1-800-FDA-0178
  • This voluntary recall is being made with the knowledge of the U.S. Food and Drug Administration.

    About QualitestFounded 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 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
    2. Qualitest Receives FDA Approval for Levetiracetam Extended-Release Tablets, 500mg and 750mg
    3. Fero Industries, Inc. Issues Corporate Update
    4. CSL Behring Parent Company, CSL Limited, Issues Fourth Corporate Responsibility Report
    5. Ranbaxy Issues Voluntary Nationwide Recall of 41 lots of Atorvastatin Calcium Tablets 10 mg, 20 mg and 40 mg Due to Potential Presence of Foreign Substance
    6. Emmaus CEO Yutaka Niihara, M.D., Issues Statement In Connection with Status of Companys Phase III FDA Sickle Cell Treatment Trials
    7. Zi Xiu Tang Success, LLC Issues Voluntary Nationwide Recall of Classic Zi Xiu Tang Bee Pollen Capsules and Ultimate Formula Capsules due to Undeclared Sibutramine
    8. CORRECTION: Star Scientific Issues Statement Correcting the Underreporting of the "Flint" CRP Human Study Results
    9. Sun Pharmaceutical Industries, Inc. Issues Nationwide Voluntary Recall of One Lot of Nimodipine Capsules due to Crystallization of the Fill Material
    10. Health Outcome Liaisons Improve Decision Making for Pharmaceutical Industry Challenged by Reform and Compliance Issues
    11. Joint Commission Issues Sentinel Event Alert on Opioid-Induced Respiratory Depression
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:5/15/2017)... 2017  Amy Baxter MD, chief executive officer and ... pain relief, was awarded a 2017 Top 40 Healthcare ... recognized at the MM&M Top 40 Healthcare Transformers dinner ... on May 10, 2017. The dinner followed a ... "beyond the pill."  "Innovation goes beyond invention," ...
    (Date:5/10/2017)... , May 10, 2017 Global Health Intelligence ... Latin America , published its 2017 ranking of ... is based on extensive data analysis from GHI,s hospitals ... hospitals database for the region. The GHI database covers 86% ... offering more than 130 data points for each institution in ...
    (Date:5/9/2017)... , May 9, 2017  Demonstrating its ... board of directors for the Pharmaceutical Research and ... for membership. Biopharmaceutical companies will now have to ... order to be eligible to join PhRMA. ... the board is sending a clear message that ...
    Breaking Medicine Technology:
    (Date:5/23/2017)... Beach, CA (PRWEB) , ... May 23, 2017 ... ... Certified Facial Plastic and Reconstructive Surgeon Dr. Kevin Sadati, is pleased to announce ... interested in building collagen and elastin in their face, neck, and body through ...
    (Date:5/23/2017)... ... May 23, 2017 , ... MedTech ... in the modern ART laboratory, to provide hands-on training utilizing cutting-edge equipment at ... NextGen LifeLabs, a MedTech Group Purchasing vendor , will provide specialized equipment ...
    (Date:5/23/2017)... ... May 23, 2017 , ... Orbita’s Nathan Treloar will discuss the role of ... Francisco. Titled Connected Health and IoT: Technology Innovators and Disruption , the workshop ... Associates, a market research and consulting firm specializing in emerging consumer technology products and ...
    (Date:5/23/2017)... ... ... Therachat , a smart guided journaling tool for improving mental health, ... of anxiety in support of National Mental Health Awareness Month. , The nationwide survey ... general anxiety levels as well as identified the top triggers, impact to regular activities ...
    (Date:5/22/2017)... ... 2017 , ... Patients who avoid necessary dental and endodontic treatments because of ... NY from Advanced Endodontics of Westchester. This highly-trained team of endodontists offer three different ... sedation methods may be recommended based on the severity of the anxiety experienced by ...
    Breaking Medicine News(10 mins):