WOW! Re: digitek recall

[Guest guest]

Actavis Totowa LLC notified healthcare professionals of a Class I

nationwide recall.

For those studying for PTCB or ExCPT be sure to know what a Class I,

II or III recall is. Go to the File #5 for tutorials on this.

Jeanetta Mastron

> >

> > 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.

> >

>