Guest guest Posted April 30, 2008 Report Share Posted April 30, 2008 Dear Dora, Thank you for this post! It is VERY important that everyone know exactly how important this is! Digoxin has a VERY NARROW therapeutic window. This means that if you give a specific amount you cannot go over that amount by very much. Mathematically the Therapeutic Index is equal to or less than 1. This means that if you give one tablet of 0.125 mg that is what is needed for a specific patient, don't even think that giving a second one of 0.125 mg is not going to be a problem to the patient just because it is available in 0.25mg! Digoxin is a cardiac glycoside which increases the FORCE of contraction in order to move blood through the heart. This is NOT a drug to play around with or that has much leeway or play in it. Taking two ASA or two Tylenol (APAP) 325 mg will not harm a healthy person with a headache. In fact it will not harm the healthy person who does not need it or have a HA. But taking any digoxin when one does not need it, does nto have any problems with blood flow or heart contractions or taking more than is prescribed could lead to overworking the heart or irregular heart beat or death! So I ask all of you who are currently working as techs to check your shelves carefully to remove this RECALLED drug. Remember you only have to remove the drug that is recalled (note the specific mfgs and lot numbers). This is to serve as a tutorial for those studying for the PTCB exam or to become a better tech. The purpose is to present the IMPORTANCE of recalls and that one must react swiftly. Let it be known that this is a REAL recall. Respectfully, Jeanetta Mastron CPhT BS Founder/Owner > > FYI (from the FDA site) > Dora > *********************************************************** > Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) > recalls all lots of Bertek and UDL Laboratories Digitek® (digoxin > tablets, USP) as precaution > Contact: > Stericycle customer service > 1-888-276-6166 > > FOR IMMEDIATE RELEASE -- town, NJ -- April 25, 2008 -- Actavis > Totowa LLC, a United States manufacturing division of the > international generic pharmaceutical company Actavis Group, is > initiating a Class I nationwide recall of Digitek® (digoxin tablets, > USP, all strengths) for oral use. The products are distributed by > Mylan Pharmaceuticals Inc., under a " Bertek " label and by UDL > Laboratories, Inc. under a " UDL " label. > > 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 it 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 illnesses 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. > > This recall is being conducted with the knowledge of the Food and > Drug Administration. > > Any adverse reactions experienced with the use of this 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 MedWatch, FDA, 5600 Fishers Lane, Rockville, MD > 20852-9787, or on the MedWatch website at www.fda.gov/medwatch. > Quote Link to comment Share on other sites More sharing options...
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