On March 31, 2009,
Caraco Pharmaceutical Laboratories, Ltd. announced a voluntary recall 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. The tablets are being recalled because
they may differ in size and therefore could have more or less of the active ingredient,
Digoxin. 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 round biconvex yellow tablet imprinted with
“437”
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Caraco Digoxin 0.25 mg is a scored round biconvex white
tablet imprinted with “441” |
NDC Numbers:
Digoxin Tablets, USP, 0.125 mg
57664-437-88 (100-count)
57664-437-18 (1000-count) |
Digoxin Tablets, USP, 0.25 mg
57664-441-88 (100-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.
For return instructions or any customer service related to this recall, pharmacies
and patients are advised to call Stericycle at 888-228-5053. Representatives are
available Monday through Friday, 8 AM to 5 PM EST.
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.
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