Heads up! New recall on digoxin. Class one by Avatis/UDL/Mylan all lots and strengths of tablets. This information is not yet listed will all wholesalers please visit the FDA website.

As a second note ISMP is having a teleconference on May 7th covering safty in purchasing.

Name of Facility: Mid Coast Hospital

City, State: nfp

Years as a Buyer: 6

Thanks so much for the heads-up!
This sure isn't something I want to deal with this week--semi-annual inventory on Wednesday!

Name of Facility: PORTER

City, State: acute care

Years as a Buyer: 9+

Good morning!

Excellent information. For what it is worth, I signed up for the email notification from the FDA on recalls. This is an excellent service. One of the 3 mentioned recalled vendors came out yesterday on the email.

Where do you sign up for the ISMP teleconference?

Thanks

Name of Facility: St. Francis Health Center

City, State: Acute

Years as a Buyer: 5 in health care & 20+ in retail hard goods

The teleconference registraion is on the ISMP website there will be 1.5 credits. On May 7th from 1:30 to 3:00pm. It seems expensive at $195.00 but my director was more than glad to pay the price seeing as it is about safty.

Name of Facility: Mid Coast Hospital

City, State: nfp

Years as a Buyer: 6

Has anyone heard additional information on the Digitek recall? For instance, is it truely a matter of the tablets being "double the thickness"? If so, we could do a visual inspection of the tablets we have on-site and not have to send them all back. Or does anyone have specific lot numbers assocaited with the recall?
I ordered in some Lanoxin in bulk bottles but would prefer not to pre-pack and trade out everything if I don't have to.

Thanks!

Name of Facility: St. Joseph Mercy Hospital

City, State: Acute Care Hospital

Years as a Buyer: 2+

I get emails from Medwatch. It doesn't say which lots....just all lots. I attached the email if you haven't already gotten it.
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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.

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Name of Facility: St. Mary's Health Center

City, State: Teaching hospital

Years as a Buyer: 28 years

The email recall alert is something you all should be getting. That kind of information you need now. not later.

I just put the FDA Recall page link on the Buyers Resources page (Subscribers Only section, maybe later I'll put it in the general section), but you can also sign up for the email alerts from there.

Name of Facility: Pharmacy Purchasing Outlook

City, State: Newsletter

Years as a Buyer: 30+