Recall Notice For Digitek Marketed Under Bertek Label Goes Back To March 2006

North Carolina Board Of Pharmacy Has Posted A Copy Of The Bertek Digitek Drug Recall Notice On Its Web Site

(Posted by Tom Lamb at DrugInjuryWatch.com)

The home page of the North Carolina Board of Pharmacy (NCBOP) currently shows a May 5, 2008 news item about the Digitek recall which includes a link to this document, which they describe as the "recall notice" (7/30/08 update: this Digitek recall notice is still on NCBOP site but off the home page, now):

Urgent: Drug Recall -- Digitek® (digoxin tablets, USP)

• Recall initiated by the manufacturer: Actavis Totowa LLC (formerly known as Amide Pharmaceuticals, Inc.)
• Product Distributed by: Mylan Pharmaceuticals, Inc. under a "Bertek" Label

Therein, we are told that this Digitek recall, at least for Bertek tablets, goes back all the way to March 2006, more than two years before the April 2008 announcements by Actavis and the FDA:

Mylan Pharmaceuticals Inc. is continuing a voluntary recall of the Actavis Totowa recall of Digitek® (digoxin tablets, USP).  This product is being recalled 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. Product was distributed nationwide between March 2006 and April 2008.

(Emphasis added.)

The NCBOP May 5 news item also reminds North Carolina pharmacists that because digoxin is a so-called "Narrow Therapeutic Index" drug, they have special obligations under North Carolina law:

A prescription for a narrow therapeutic index drug shall be refilled using only the same drug product by the same manufacturer that the pharmacist last dispensed under the prescription, unless the prescriber is notified by the pharmacist prior to the dispensing of another manufacturer's product, and the prescriber and the patient give documented consent to the dispensing of the other manufacturer's product. For purposes of this subsection, the term "refilled" shall include a new prescription written at the expiration of a prescription which continues the patient's therapy on a narrow therapeutic index drug.

N.C.G.S. Section 90-85.28(b1).

In their May 2008 news item, the NCBOP acknowledged that the Digitek recall is "unusual" as concerns pharmacist-compliance with this NC statute:

Board staff understands that the Digitek recall will require switching some patients to a different manufacturer’s digoxin product. Compliance with the letter of N.C.G.S. Section 90-85.28(b1) may prove difficult in certain circumstances. In the unusual circumstances of this recall, it is critical to ensure that patients continue to receive their medication. Accordingly, where switching a patient to a different manufacturer’s digoxin product is necessary because of the recall, pharmacists must counsel affected patients on the switch, the reason for it, and possible side effects/therapeutic changes that could be associated with the change. Moreover, pharmacists must contact the patient’s prescriber to alert of the change so that monitoring of digoxin levels and therapeutic effect can, if necessary, begin.

Interestingly, the Digitek recall notice posted on the North Carolina Board of Pharmacy (NCBOP) web site makes no mention of the Digitek pills marketed under the "UDL" label and distributed by UDL Laboratories, Inc. -- part of Mylan Laboratories, Inc. which also includes Mylan Pharmaceuticals, Inc.

One reason may be that UDL apparently provided Digitek in pharmaceutical unit dose packaging for hospitals, nursing homes, and other healthcare institutions, only.  As such, perhaps that aspect of the Digitek recall is not a matter of concern for the NCBOP.

Let us know if you have any news or information about the Digitek recall that we can share.

Comments

[Tom Lamb]

It is astounding to me that in this day and age a U.S. prescription drug manufacaturing facility -- the Actavis plant in Little Falls, NJ -- could be operating for years without an effective quality control system in place.

Your mother's situation is not unique, as other unsuspecting patients were being harmed by a medicine that was suppose to improve their health. That being the case, however, does not diminish the suffering and, most likely, confusion your mother went through when the Digitek hurt instead of helped her.

I am glad your mother is feeling better these days.

Thanks for reading Drug Injury Watch.

Tom Lamb

[Carol]

My mother is on digitek and is currently feeling a little better but for the last couple of years prior to the recall she was really sick she would get really sick after taking her digitek but we never made a connection until the pharmacy told us of the recall and we searched for the side effects of the double dose and bingo there it was. She would tell us she thought she was dying thats how ill she was. Its awful to think that she was indeed dying from the toxins.

[Tom Lamb]

I am sorry to hear about the sudden loss of your father.

Let me know if you are interested in having us investigate whether Digitek pills may have played a role in the death for the purpose of a possible wrongful death case.

Thanks for reading Drug Injury Watch.

Tom Lamb

[Lisa Tuetken]

My father was taking Digitek and at the time was doing quite well. When all of sudden Quite unexpectedly he passed away. Right after his personal cardeoligist told him he was doing so good. After being seen once a month for almost a year my father was told he would not have to come back for 6 months. Then a week later he fell asleep and didn't wake up. That was on October 10, 2007. Then i hear that his heart medication has been recalled due to serious side effects including DEATH.

[Tom Lamb]

I appreciate you sharing your experience with Digitek, and hope you are on the road to recovery.

As requested, I will call you the first part of this week about your possible claim for legal compensation.

Thanks for reading Drug Injury Watch.

Tom Lamb

[Judy Chenard]

I was put on Digitek on April 21st of 2008. I was having atrial fibulation with some heart fluttering. On May 2nd, I was informed that I should stop it at once, because of a recall. During this time span I was on oxygen 24/7, with a terrible cough.

On May 4th, I went to the emergency room as I was having trouble breathing and my fac was turning funny colors. In no time at all,I was hooked up to a crash cart, as my heart rate was in the
30's. This was at Bay Area Hospital in Marinette,Wi. I was admitted into the ICU and the next day I was sent to St Vincent's in Green Bay.Wi and then on May 7th, I was sent to Aurora Sina in Milwaukee, Wi where I finally had 2 procedures done , including a pace maker.

I feel that this medication is the cause of my problems. Thedoctor and I were going to wait until late May or early June as I was doing fairly well until then.

I would like to have a recommendation of a lawyer who would take this if not you.

Sincerely yours
Judy

[Tom Lamb]

I appreciate you taking the time to let us know this information about what you were told about the dates involved with the Digitek recall by Actavis.

Another person recently told me that his pharmacist had called the "company" (or their crisis-control contractor) and his pharmacist was told something similar. At present, I can't remember where he was located. I think he was in Wisconsin.

We welcome any other information or news about the extent of this Digitek recall -- in terms of time periods and estimated number of defective Digitek tablets "accidentally released" by Actavis -- from anyone who has something that might further develop this evolving story.

Thanks for reading Drug Injury Watch.

Tom Lamb

[annie]

Hello,

I called Activas after a friend was told to stop taking Digitek immediately. I asked explicitly how long the double dose tablets had been in circulation, and first the woman said it depended on what country you lived in, but I pressed her for more information, and she put me on hold a second time and came back with "two years."

This corresponded with the digitalis toxicity symptoms she had been having over this period of time, including repeated hospitalizations for arrhythmias, swelling, etc. She's 79, and won't consider suing the bastards.

Thought you might be interested in that time frame direct from the company. (We're in Oregon).

Annie