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You are here: Home / Featured / Caraco Brand Digoxin Recalled Due to Size Variability

Caraco Brand Digoxin Recalled Due to Size Variability

May 13, 2009 By The FDA 3 Comments

caraco-digoxinThe drug repackaging company A S Medication Solutions, LLC has announced a recall on all Caraco brand digoxin, USP, 0.25 MG tablets distributored before March 31, 2009, which are not yet expired and are within the expiration date of August, 2011.

The Caraco digoxin tablets have been recaled because they may have size variations, which could result in the pill having more or less of the active medication digoxin. As noted in earlier digoxin recalls, overdosing on this drug could result in serious health complications, including cardiac arrest and death.

Digoxin is used to treat heart failure and abnormal heart rhythms, and has a narrow therapeutic index, meaning it is easy to under or over dose on this drug, resulting in digoxin toxicity. The symptoms of digoxin toxicity include nausea, vomiting, dizziness, low blood pressure, unstable heartbeats and slow heart rates, which could also result in death.

Consumers with digoxin tablets that have the following NDC codes should consult their doctor immediately. NDC Numbers: Digoxin Tablets, USP, 0.25 MG 54569-5758-0 (30-COUNT)

PRODUCT IDENTIFICATION
Caraco Digoxin A-S Medication Solutions. Digoxin, 0.25 MG is a scored, round biconvex white tablet with “441&RDQUO printed on it.

The A-S Medication Solutions press release issued through the FDA Medwatch Program advised consumers to return their pills to the pharmacy. However, realize that returning your proof of oversized tablets may have an effect on your ability to bring a legal claim against the company if you have been a injured as a result of digoxin toxicity.

You should consult with your physician immediately if you think you may have been taking under-sized or over-sized Caraco digoxin tablets.

Healthcare providers can call A-S Medication Solutions at (847) 680-3515, Monday through Friday from 8:am – 4:pm for instructions on how to return the recalled Caraco digoxin.

Adverse reactions associated with the use of dogoxin should be reported the the FDA Medwatch Program by phone at 1-800-FDA-1088 or on their website: www.FDA.gov/medwatch.

Note: This is a new digoxin recall for Caraco brand digoxin and is unrelated to the original Digitek brand digoxin recall announced in April, 2008.

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About The FDA

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

Comments

  1. salvatore albanese says

    October 14, 2010 at 4:08 am

    i haven been taken digoxin 0.125mg tab for the past 7 years
    i receive them from veterans affairs i have asked them if i have the the right pills they tolled me that they were ok.

    i just hope so

    thank you

    Reply

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