Posted on 05/12/2008 2:01:27 PM PDT by TennesseeGirl
Morristown, NJ - The manufacturer of Digitek digoxin tablets is recalling the product, saying that it may have accidentally released pills that are double the normal thickness, carrying twice the normal dose [1].
Digoxin is used in the treatment of arrhythmias and heart failure, and a double dose could cause toxicity, most notably in patients with renal failure. According to a press release from Digitek's manufacturer, Actavis, digitalis toxicity "can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia," and even death.
The FDA is alerting doctors and the public to the recall via its MedWatch program. The agency notes that several reports of illness and injury have been reported. Digitek is distributed by Mylan Pharmaceuticals under a Bertek label and by UDL Laboratories under a UDL label, the Actavis press release notes.
(Excerpt) Read more at theheart.org ...
LOL. These product liability threads just always remind me of the logic behind global warming:
* Is the faulty product from China?
YES-> Aha! Proof that all China products are dangerous.
NO-> Aha! Not this time. But China products ARE dangerous.
Thanks for the recall link. My dad’s pills are not in a bottle. They are in 4 rows (7-8-8-7) of those push out kind on flat foil that slide into a plastic holder.
It says “SUB>DIGITEK 0.125MG TAB UDL LABS”
He got the prescription filled at WalMart on 04/04/2008.
He has been taking these for some time. He had a similar episode in Arizona in January (while at my sister’s house). At that time she also called 911 and he was in the hospital for several days.
The cost of 1 life isn’t worth importing drugs of questionable quality.
Get it? Got it? Good!
It DOES NOT MATTER whether the 'questionable drugs' were imported from China or Canada or manufactured at Eli Lily in Indianapolis.
It amazes me that Americans won't buy American cars because the union thug quality is so poor, but somehow, someway they think that the quality of other manufacturing processes in the US, operated by the same people who voted 50% for Kerry and Gore are somehow immune from sloppy work that screws up a mixture/product/assembly like this.
You need independent screening for EVERYTHING...no matter where it's made.
You are welcome, I know you worry about what your loved ones are taking.
Is your dad doing ok?
Did you call the druggist and ask if he might have had the wrong type?
If they put too much in the pill, do they also put in too little?
I talked to the Walmart pharmicist’s aide yesterday. She deferred to the pharmicist after I showed her the recall letter (Thanks TennesseeGirl). The pharmacist told me that all product had been recalled (? not according to the letter) including the push out foil packages of my dad’s prescription. They told me to call the number given on the recall letter and to consult my dad’s physician. They would fill an alternative lanoxin prescription and hold it for us to pick up on his doctor’s recommendation.
I did not ask any questions. I did let them know that my dad was in the hospital a couple of weeks ago after having experienced what I thought was a heart attack/convulsions.
Health/life BUMP!
All this medicine mistakes gets scary.
Did the doctor order a change in the meds?
How is your dad doing now?
Yes, he has gone from LANOXIN 0.125 MG (push-out from foil tab) SUB>DIGITEK 0.125MG TAB UDL LABS...
...to LANOXIN 0.125 mg SUB>DIGOXIN 0.125 MG TAB CARACO (regular pill bottle)
If you ask me the difference between the 2 and how it relates to the "URGENT: Drug Recall" notice,...I HAVE NO CLUE.
The article TGirl posted mentioned UDL Laboratories (what he was taking). The Urgent: Drug Recall did not.
My dad seems to be doing fine, now.
Health/life BUMP!
Caraco looks like a booming business right in my own backyard...Detroit, Michigan (New Center area)...
http://www.caraco.com/History.htm
parts of Caraco CEO’s statement...
“Simultaneously, we will pursue other avenues of development including but not limited to our own internal development, working with development partners or third party formulators, in-licensing of authorized generics and acquisitions of ANDAs that may or may not be currently marketed by other pharmaceutical companies.”
“In the last ten years the generic industry has evolved from domestic research and development teams to what is now a more global effort. Our development is consistent with this evolution. This has allowed us to reduce or eliminate costs in developing our product portfolio while improving output. This is our fiduciary role and allows us an opportunity to do our part in curbing healthcare costs in the US while maximizing the return on investment for our shareholders. Caraco is part of a global pharmaceutical solution.”
statements from Daniel H. Movens - C.E.O.
http://www.caraco.com/CEOMessage.htm
third party formulators<<<
That leaves a lot open to bad prescriptions.
I was curious, page 2:
News: 1 link.
Interesting, they are excited about using third parties:
Recalls:
My dad seems to be doing fine, now.<<<
Thank God.
I am so very glad.
Exactly. Interesting that the CEO's statement fails to mention the end user, the patient/customer. Then again the pharmacist could be seen as the customer, the doctor...the pusher, the patient...the guinea pig. /sarcasm
WASHINGTON (Reuters) May 15 - Generic drugmaker Lannett Co on Thursday said it is working with U.S. regulators to ensure a safe supply of digoxin, following a recall of another version of the drug.
The Food and Drug Administration late last month announced the recall of the Digitek brand of digoxin, sold by Actavis Totowa and distributed by Mylan.
Lannett said it has secured additional active ingredients to meet U.S. demand.
The FDA said the Digitek tablets may contain twice the amount of the active ingredient, which could put patients at risk, including the possibility of death. http://www.medscape.com/viewarticle/574575
Health/life BUMP for FReepers & lurkers. Thanks for the latest, TGirl. (Not much info on who, when, where, how many, etc., etc. may have been affected or perished)
After almost a week of testing and lots of meds, the function was back up to 50%, so I went home with prescriptions for Digitek, lisinopril, carvedilol, lasix, and warfarin. Thank God for Wal-Mart's $4 generics program! I went back last month for a follow up Echo, and my heart was back to full function, and he took me off everything except the BP meds. The tests in the hospital showed NO blockages, heart damage, or even any heart disease, so they think it must have been a virus that attacked my heart. I've known for years that I have a 'wiring problem' and I'll get A-Fib from time to time. I've been taking a low dose aspirin every day for years, but bumped it up to a full dose, when the Doc took me off the warfarin during a follow up visit in mid.-Feb.
Thanks for the update.
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