[NRSKarenRN]

Tablets May Contain Twice Approved Level of Active Ingredient

Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms. The products are distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label. The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of its active ingredient. 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. Several reports of illnesses and injuries have been reported. Patients should contact their healthcare professional with questions.

Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Digitek

[NeaNea]

I am a home care nurse and received a phone call from an elderly patient regarding a letter she received from her pharmacy about the Digitek recall. She was confused due to the complexity of the letter, which basically informed her of the recall, but offered no direction of action. Per her request, I phoned her pharmacy (large nationwide chain) which gave instructions for patients to bring their prescription bottles and notifications in for further direction regarding replacements.

[calliesue]

Had a pt recently with dig toxicity in my ltc, I am going to see if I can find her digoxin. Very interesting.

[1BlessedRN]

this is true folks, huge recall...we had 8 cards plus tabs already consumed by pts to send back to pharmacy thank goodness the stat dig level labs were all ok~

[Mimi2RN]

My husband takes digoxin, and the last refill was Digitek, about a couple of weeks before the recall. We had a call from the pharmacist who told him not to take any more of that prescription.

The next day, my husband had nausea, vomiting, dizziness. I went to pick up the new Rx, and told the pharmacist about the problems. He agreed with me that a dig level was needed. I called the cardiolgist, got the dig level ordered and drawn. Heard nothing that day, but I contacted the office the next morning and later we heard his level was WNL.

We received an envelope from the manufacturer, as they want all the pills back. Supposedly, they will be returning the cost of the meds.

A little scary at the time, but we figure it must have been some kind of 'flu bug, the next day he was fine!

[JOHNCHE]

I work the ED as well as the surgical floor, the first heard of this i was in the ED and recieved a call, a woman telling me her phamasist told her to return her dig as it was recalled, an really didn't giver any more info than just that, I notified our phamisist and was told that was true, he had just recieved a fax that morning. Two days later on the surgical floor I had a patient with an elevated dig level, who did show s/s of dig toxicity bradycardia and new onset of A-fib nausea, diarrhea ect. Kind of concerning is it not. what about heparin, we had all 5000 u viles removed from our hosp. but doc were still ordering hep drips, our protocal requires a loading dose of 5000 u / and starting the drip at 10,000/hr what the docs were ordering was a bolus from the premix hep and then start the drip at 10,000 u /hr this was deemed to dangerous by our pharmisist and now its lonenox all the way, haven't hung a bag of hep in months.

[chevyv]

I have an 11 yr old child on Dig and have to tell you all that I was shocked when I received a letter regarding the recall. The letter was dated May 10 and I finally got it May 18. I called the number of the med company and do you think I got a live body? NO I called Walgreens (who sent the letter) and verbally spanked them for the slow response. The recall was for the past year! Hello, a whole year???? I went back to Walgreens and checked the new pills and sure enough, they were smaller (but who knows about the dose). My son did tell me that at night he could see those pretty lights (dig tox perhaps?). His cardiologist tells me that there isn't anything they can really do if his levels are up. Eventually, they will come down (Yea, like I'm feeling better-not). We have our check up next Monday with complete blood work.
It's difficult when you have to take meds to survive and companies make these kind of errors. Scary and sad.