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 Tablets, USP, 0.25 mg
    57664-437-88 (100-count)                57664-441-88 (100-count)
    57664-437-18 (1000-count)               57664-441-18 (1000-count)

Patients using Caraco's Digoxin tablets, USP, 0.125 mg or 0.25 mg, who have medical questions should contact their healthcare provider for additional instructions or guidance.

Retailers who have this product should return the product to their place of purchase. Retailers can call Caraco customer service at (800) 818-4555, Monday through Friday, 8:00 a.m. - 5:00 p.m. EDT, for instructions on how to return the affected product or for any other inquiries related to this action.

Any adverse reactions experienced with the use of all affected product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at Med Watch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.

Safe Harbor: This news release contains forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based on management's current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties are contained in the Corporation's filings with the Securities and Exchange Commission and include, but are not limited to: information of a preliminary nature that may be subject to adjustment, potentially not obtaining or delay in obtaining FDA approval for new products, governmental restrictions on the sale of certain products, development by competitors of new or superior products or less expensive products or new technology for the production of products, the entry into the market of new competitors, market and customer acceptance and demand for new pharmaceutical products, availability of raw materials, timing and success of product development and launches, dependence on few products generating majority of sales, product liability claims for which the Company may be inadequately insured, and other risks identified in this report and from time to time in our periodic reports and registration statements. These forward-looking statements represent our judgment as of the date of this report. We disclaim, however, any intent or obligation to update our forward-looking statements.


'/>"/>
SOURCE Caraco Pharmaceutical Laboratories, Ltd.
Copyright©2009 PR Newswire.
All rights reserved

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:
(Date:5/24/2016)... ... May 24, 2016 , ... Educational opportunities, ... housing, with more advantaged communities providing richer opportunities. Recognizing the key role of ... school improvement policies; (b) school choice policies; (c) school desegregation policies; (d) wealth-focused ...
(Date:5/24/2016)... ... ... New Brunswick, New Jersey: This year marks Children’s Specialized Hospital ’s 125th anniversary ... anniversary, the hospital has themed the milestone “Hats Off” and kicked off the yearlong ... Saturday, May 21, at Johnson Park in Piscataway, New Jersey. , “Hats ...
(Date:5/24/2016)... ... (PRWEB) May 24, 2016 -- Grow Healthy ... Advisory Board. Joining the Grow Healthy Advisory Board team are ... embody the mission of our organization and bring talent, expertise and ... as we continue to expand our footprint as the leader in ...
(Date:5/24/2016)... ... May 24, 2016 , ... Boyd Industries, a leading supplier of ... groundbreaking new product for pediatric dentistry , at AAPD 2016, the annual conference ... May 26-29. The Concealed Delivery Unit keeps dental hand pieces and other anxiety-provoking pieces ...
(Date:5/24/2016)... ... May 24, 2016 , ... Eggsurance, the first independent, non-clinic ... its community and education hub for women considering fertility preservation, as well as ... safe and welcoming place for women to find cycle buddies, get clinic recommendations ...
Breaking Medicine News(10 mins):
(Date:5/24/2016)... 2016 The innovator of ... , s first dual therapy stent, introduces catheters ... OrbusNeich, a global company specializing in the provision ... include products to treat peripheral artery disease. The JADE™ ... devices for lower limb and arteriovenous (AV) fistula intervention. ...
(Date:5/24/2016)... , May 24, 2016 Dutch surgeons ... best practices around the world and treat patients on a global ... Africa , Asia and the US ... with instant messaging and networking in a totally secure environment. ... in a war zone working together with a surgeon at Harvard ...
(Date:5/23/2016)... FLINT, Mich. , May 23, 2016 Diplomat ... the third annual Fellowship and Internship programs. The hands-on ... 12. The full-time, paid Fellowship ... Flint, Michigan . Fellows and interns are ... downtown Flint at the Riverfront ...
Breaking Medicine Technology: