St. Johns Cardiovascular St. Augustine Florida USA

St. John's Cardiovascular, P.A.

Howard A. Baker III, M.D., F.A.C.C.

St. Augustine Florida USA

 

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Digitek Brand Digitalis Recalled:  April 2008

 

What happened?

Actavis Totowa manufactured some Digitek-brand tablets that might contain twice the amount of digitalis that is intended.

 

How will  I know if my digitalis is affected?

            Only Digitek-brand tablets manufactured by Actavis are affected.  All lots and all strengths have been recalled.

 

How will I know if am having a toxic reaction from too much drug?

Symptoms can  include nausea, vomiting, dizziness, slow or irregular heart rhythm, low blood pressure and, rarely, death. 

 

What should I do?

Replace your digitek immediately at the pharmacy that sold it to you.

No lot numbers appear on the pills, so any digitalis manufactured by Actavis and distributed by Mylan Pharmaceuticals (under a Bertek label) should be returned to the pharmacy where you got it for replacement with another brand.

If you are having any of the symptoms of a toxic reaction, you should call your doctor and discuss your symptoms.

 

Where can I get more information:

Reproduced below are excerpts from Actavisí website.

Call your doctor if you have further concerns. 

 

The voluntary all-lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released.  These tablets may contain twice the approved level of active ingredient than is appropriate. 

Digitek is used to treat heart failure and abnormal heart rhythms.  The existence of double-strength tablets poses a risk of digitalis toxicity in patients with renal failure.  Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive Digitalis intake.  Several reports of illness and injuries have been received. 

Actavis manufactures the products for Mylan and the products are distributed by Mylan and UDL under the Bertek and UDL labels.  Bertek and UDL are affiliates of Mylan.

Any customer inquiries related to this action should be addressed to Stericycle customer service at 1-888-276-6166 with representatives available Monday through Friday, 8 am to 5 pm EST.  Additional information about the voluntary recall can also be found at www.actavis.us

Retailers who have this product are urged to return the product to their place of purchase.  If consumers have medical questions, they should contact their health care providers.

 

 

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Updated: 06/17/2010 04:47:15 PM

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