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RECALL: all lots of Bertek and UDL Laboratories Digitek® (digoxin tablets, USP) Just for Chit Chat
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Old 05-14-2008, 06:12 PM   #1
Cheesecake
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Exclamation RECALL: all lots of Bertek and UDL Laboratories Digitek® (digoxin tablets, USP)

Last Saturday my Mother's Pharmicist called her and told her to STOP taking her Digoxin (heart related) medication. Apparently there had been a bad batch, and she should just stop...and take her full bottle back to the pharmacy and get new.

Well upon further investigation, this is a NATION WIDE RECALL of this common medication.
The medication was recalled on April 25, 2008...Kaiser Permanente in California is notifying its patients on May 10, 2008. I think that is too long a wait.

Of course, I'm not an advocate of that HMO, because I've observed one after care for a heart valve by pass and two hip surgeries...the heart operation was farmed out to St. Mary's in San Francisco and the Surgeon who did the hip surgeries was a miracle worker...(unusual)...but...the after care is FRIGHTENING.

Now..with the history in the back ground...if you are taking digoxin...:

The FDA says:

Recall -- Firm Press Release


FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

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 -- Morristown, 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.
http://www.fda.gov/oc/po/firmrecalls/actavis04_08.html
_______________
Digitek is the cheaper generic version of ''Lanoxin'' digoxin.......digitalis.
Finding Lanoxin at your local pharmacy, it is being reported, is almost next to impossible.
Kaiser's pharmacy is only allowed to give 30 tablets of the Lanoxin to its patients because of the shortage.

Anyway..if you take this medication, get in touch with your Doctor if your Pharmacy has not notified you of the RECALL.
Someone said, imported from China?
Someone else said, do we dare take our pills of any kind?
Who is checking the quality?
You can google this and find message boards and blogs and all the ''horror'' stories already heading into a class action suit.
My Mother's Dr told her to take her Lanoxin, and in 10 days come for a digitalis toxicity blood test...she has had none of the symptoms of the ''bad batch'', (which are flu like - plus - fatal), and maybe no one got the bad batch from her pharmacy, but .... its a worry.
In reading the complaints by others, WalMart and Walgreens and other major pharmacies are involved in recalling and notifications........mostly by snail mail, in envelopes that are not clearly marked as ''urgent''.

Last edited by Cheesecake : 05-14-2008 at 06:20 PM.
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Old 05-14-2008, 08:37 PM   #2
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Yes, my son was taking this medication and he was notified right away! He says he gets his prescriptions at Target Pharmacy and they called him right away.
How awful of any pharmacy, whether Wal-mart or Walgreens to notify about this by snail mail, someone could be dead by then!
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Old 05-14-2008, 09:30 PM   #3
Blaze2
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My Pharmacist called me more than two weeks ago
& exchanged what was left in my prescription of digitek.
I appreciate his promptness on this issue.
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