VA SLOW TO ACT ON CLASS 1 RECALL OF POTENTIALLY

DANGEROUS HEART DRUG -- Veterans should continue

taking the drug and immediately contact their

VA physician for instructions.

(this photo has been altered to remove personal information)

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by Larry Scott

A veteran sent me the above photo of a VA prescription vial.  The vet told me he had found out, on his own, that the drug had been recalled, but he hadn't heard word one from his VA pharmacy.

The drug listed, Digoxin 0.25mg with NDC# 57664-0441-18, has been recalled by the manufacturer.  (see below)

But, to our knowledge, it has not yet been recalled by the VA.  It is not listed on the VA's Medication Safety News page, here...
http://www.pbm.va.gov/VACenterFo
rMedicationSafety-Index.aspx

To double-check on this, I called my VA pharmacy (West Coast).  They knew nothing about it.  When I gave them the NDC#, they checked and said no vets were given that lot number. 

I wondered about that.

So, I called the VA pharmacy where the prescription was filled (East Coast).  The VA pharmacist told me the same thing... they knew nothing about a recall... and they did not fill any Digoxin prescriptions with that NDC#.  How can that be?  I'm not sure.

I talked with Veterans' Advocate Jim Strickland who told me that this is a Class 1 recall, defined this way:  Class I recalls go all the way down to the consumer level and are for dangerous or defective products that predictably could cause serious health problems or death.

And, this is from a former FDA investigator:

VA departments like VA hospitals and VA District Offices tend to operate as independent fiefdoms. When you contact the VA people you know, they may know nothing of the recall and you will have to explain it to them.

You may probably find the recall notice was sent to the department that purchases the drugs and they never sent it to any pharmacy. The main VA supply depot may not have forwarded this to the pharmacy's or notified VA Administrators so the medical staff was alerted. Or the VA is unaware that this alert is down to the patient-consumer lever and can injure heart patients.

The doctors may only become aware of the problem when they read it in medical journals two months after the fact.

Well, we don't want you to find out two months after the fact.

If you are a veteran taking Digoxin with the NDC codes (lot numbers) listed below, here is what you should do.

1.  CONTINUE TAKING THIS MEDICATION.  Discontinuing Digoxin could cause very serious problems.

2.  Contact your VA physician immediately and seek guidance regarding your supply of Digoxin.

And, another complication.  There is a Digoxin shortage right now because of a number of recalls.  In fact, one manufacturer has stopped production.

Recall information is below:

                            click for more information -- a disabled veteran owned business

The FDA recall page for this drug is here...
http://www.fda.gov/oc/po/firmrecalls/caraco03_09.html

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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.

Caraco Pharmaceutical Laboratories, Ltd. Announces a Nationwide Voluntary Recall of All Lots of Digoxin Tablets Due to Size Variability

Contact:
Daniel Movens: (313) 871-8400
Thomas Versosky: (313) 556-4150

FOR IMMEDIATE RELEASE -- DETROIT, March 31, 2009 -- Caraco Pharmaceutical Laboratories, Ltd. (NYSE AMEX: CPD), a generic pharmaceutical company, announced today that all tablets of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011, are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. The recalled tablets were manufactured by Caraco Pharmaceutical Laboratories, Ltd. This recall is being conducted with the knowledge of the Food and Drug Administration.

Digoxin is a drug product used to treat heart failure and abnormal heart rhythms. It has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Consequently, as a precautionary measure, Caraco is recalling these tablets to the consumer level to minimize any potential risk to patients.

Consumers with the products with the following NDC codes that are within expiration should return these products to their pharmacy or place of purchase.

Product Identification

Caraco Digoxin 0.125 mg is a scored round biconvex yellow tablet imprinted with “437”

Caraco Digoxin 0.25 mg is a scored round biconvex white tablet imprinted with “441”

NDC Numbers:

Digoxin Tablets, USP, 0.125 mg
57664-437-88 (100-count)
57664-437-18 (1000-count)

Digoxin Tablets, USP, 0.25 mg
57664-441-88 (100-count)
57664-441-18 (1000-count)

Patients using Caraco's Digoxin tablets, USP, 0.125 mg or 0.25 mg, who have medical questions should contact their healthcare provider for additional instructions or guidance.

Retailers who have this product should return the product to their place of purchase. Retailers can call Caraco customer service at (800) 818-4555, Monday through Friday, 8:00 a.m. – 5:00 p.m. EST, for instructions on how to return the affected product or for any other inquiries related to this action.

Any adverse reactions experienced with the use of all affected 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 Med Watch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch. 

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posted by Larry Scott
Founder and Editor
VA Watchdog dot Org
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