Navigation Links
Caraco Pharmaceutical Laboratories, Ltd. Announces a Nationwide Voluntary Recall of All Lots of Digoxin Tablets Due to Size Variability
Date:3/31/2009

DETROIT, March 31 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. (NYSE Amex: CPD), a generic pharmaceutical company, announced today that all tablets of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011, are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. The recalled tablets were manufactured by Caraco Pharmaceutical Laboratories, Ltd. This recall is being conducted with the knowledge of the Food and Drug Administration.

Digoxin is a drug product used to treat heart failure and abnormal heart rhythms. It has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Consequently, as a precautionary measure, Caraco is recalling these tablets to the consumer level to minimize any potential risk to patients.

Consumers with the products with the following NDC codes that are within expiration should return these products to their pharmacy or place of purchase. 

    Product Identification
    Caraco Digoxin 0.125 mg is a scored     Caraco Digoxin 0.25 mg is a scored
    round biconvex yellow tablet            round biconvex white tablet
    imprinted with "437"                    imprinted with "441"

    NDC Numbers:
    Digoxin Tablets, USP, 0.125 mg          Digoxin Ta
'/>"/>
SOURCE  Caraco Pharmaceutical Laboratories, Ltd.
Copyright©2009 PR Newswire.
All rights reserved

1

GOOD

Page: 1 2 3 

Related medicine news :

1. Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the Third Quarter and First Nine Months of Fiscal 2009
2. Caraco Pharmaceutical Laboratories, Ltd. to Announce Third Quarter of Fiscal Year 2009 Results on January 29, 2009
3. Caraco Pharmaceutical Laboratories, Ltd. Responds to FDA Warning Letter
4. Caraco Pharmaceutical Laboratories, Ltd. Update on FDA Warning Letter
5. Caraco Pharmaceutical Laboratories, Ltd. to Market Generic Sinemet(R) Tablets
6. Caraco Pharmaceutical Laboratories, Ltd. Reaches Agreement with Labor Union
7. Caraco Pharmaceutical Laboratories, Ltd. to Market Generic Depakote(R) Delayed Release Tablets
8. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Elavil(R)
9. Caraco Pharmaceutical Laboratories, Ltd. Reports Record Results for the Fourth Quarter and Fiscal Year 2008
10. Caraco Pharmaceutical Laboratories, Ltd. to Announce Fourth Quarter and Fiscal Year 2008 Results on May 29, 2008
11. Caraco Pharmaceutical Laboratories Ltd. Wins Summary Judgment on Generic Ultracet(R)
Post Your Comments:
*Name:
*Comment:
*Email:
Breaking Medicine Technology:Reportlinker Adds South Korean Market for Dental Implants and Final Abutments 2009 2Reportlinker Adds South Korean Market for Dental Implants and Final Abutments 2009 3Reportlinker Adds South Korean Market for Dental Implants and Final Abutments 2009 4Reportlinker Adds South Korean Market for Dental Implants and Final Abutments 2009 5Reportlinker Adds South Korean Market for Dental Implants and Final Abutments 2009 6Reportlinker Adds Cardiac Biomarkers - A Global Market Perspective 2Reportlinker Adds Cardiac Biomarkers - A Global Market Perspective 3Reportlinker Adds Cardiac Biomarkers - A Global Market Perspective 4Reportlinker Adds Cardiac Biomarkers - A Global Market Perspective 5Reportlinker Adds Cardiac Biomarkers - A Global Market Perspective 6Reportlinker Adds Cardiac Biomarkers - A Global Market Perspective 7Reportlinker Adds Cardiac Biomarkers - A Global Market Perspective 8Reportlinker Adds Respiratory Care Equipment & Supplies - A Worldwide Market Review 2Reportlinker Adds Respiratory Care Equipment & Supplies - A Worldwide Market Review 3Reportlinker Adds Respiratory Care Equipment & Supplies - A Worldwide Market Review 4Reportlinker Adds Respiratory Care Equipment & Supplies - A Worldwide Market Review 5Reportlinker Adds Respiratory Care Equipment & Supplies - A Worldwide Market Review 6Reportlinker Adds Respiratory Care Equipment & Supplies - A Worldwide Market Review 7Reportlinker Adds Respiratory Care Equipment & Supplies - A Worldwide Market Review 8Reportlinker Adds Respiratory Care Equipment & Supplies - A Worldwide Market Review 9GE Healthcare President 26 CEO Mark Vachon to Present at BioConference Live 10595 1GE Healthcare President 26 CEO Mark Vachon to Present at BioConference Live 10595 2Hepatitis B does not increase risk for pancreatic cancer 60451 1Toronto Conference Targets the Vitamin D Deficiency Crisis 60448 1Toronto Conference Targets the Vitamin D Deficiency Crisis 60448 2Toronto Conference Targets the Vitamin D Deficiency Crisis 60448 3
Other Medicine Technology:Rosetta Genomics to Present Multiple Posters at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) 2Rosetta Genomics to Present Multiple Posters at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) 3Rosetta Genomics to Present Multiple Posters at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) 4Rosetta Genomics to Present Multiple Posters at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) 5Rosetta Genomics to Present Multiple Posters at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) 6Eisai's Commitment to Oncology Demonstrated by Clinical Data to be Presented at ASCO Annual Meeting 2Eisai's Commitment to Oncology Demonstrated by Clinical Data to be Presented at ASCO Annual Meeting 3Eisai's Commitment to Oncology Demonstrated by Clinical Data to be Presented at ASCO Annual Meeting 4Eisai's Commitment to Oncology Demonstrated by Clinical Data to be Presented at ASCO Annual Meeting 5Eisai's Commitment to Oncology Demonstrated by Clinical Data to be Presented at ASCO Annual Meeting 6Eisai's Commitment to Oncology Demonstrated by Clinical Data to be Presented at ASCO Annual Meeting 7Eisai's Commitment to Oncology Demonstrated by Clinical Data to be Presented at ASCO Annual Meeting 8