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At the bottom of this Page is the official explanation of Drug Recalls and definitions of what the Class code means.

 

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June 10, 2004

ProHeart- INJECTABLE- RECALLED-Failing dissolution (see below)

Hi Folks,

Here is the Notice of the heartworm drug recall (below).

So, does failing dissolution at 6 months mean that the drug that was INJECTED into the dog as a heartworm preventative simply stayed in the injection site?

Does this mean that there wasn't really any heartworm prevention?

What about that drug staying in the animal and not DISSOLVING? Will a SURGICAL procedure now be NEEDED?

Will there be LONG-TERM adverse affects as a result of that drug not breaking-down and then having the dog's body (liver/kidney/skin) detoxify it?

Who knows the answer to these questions?

FDA Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II

June 9, 2004

(edited with highlights/bold type/italics, for emphasis)

PRODUCT
Fort Dodge  ProHeart 6 (moxidectin) Sustained Release Injectable for Dogs,

Sterile Vehicle 17 ml. to be used to constitute moxidectin microspheres, 10% w/w moxidectin microspheres, packed in 5-unit packs of 20-ml. moxidectin microsphere and vehicle vials, RX, NADA 141-189, NDC 0856-3670-20. Recall # V-130-4.


CODE
Lot 367158214, Exp. April 05, and Lot 367158215, Exp. June 05.


RECALLING FIRM/MANUFACTURER
Fort Dodge Laboratories, Inc., Fort Dodge, IA,
by letters on April 27, 2004. Firm initiated recall is ongoing.


REASON
Failing dissolution results for the moxidectin microspheres at the 6-month stability time point.


VOLUME OF PRODUCT IN COMMERCE
7,390/5-unit packs.


DISTRIBUTION
Nationwide.

 

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June 10, 2004

Hi Readers,

So, not only are there over 2,000 Adverse REACTIONS to prescribed medications, reported PER MONTH (and most are NOT reported), there's also been Drug RECALLS because they don't work - OR have seriously INJURED animals.

Do you think that people are bringing their animals into their vet's offices for EMERGENCY visits as a RESULT of some of the SERIOUS Adverse REACTIONS?

I know that in the past, I certainly have - once when my dog, Lady had the neurotoxic reactions to ivermectin, and we had to see a SPECIALIST to find out where the Nerve Damage was! Unfortunately, he said it would be major surgery and we'd probably never know where the damage was.

Fortunately, MY vet's policy was to accept MONTHLY payments. Of course, that would NOT have been the case if I had been AWAY while traveling and my dog needed immediate medical care.

As for Drug Recalls, here is just one for ProHeart TABLETS.

 

FDA  Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

ProHeart online Petition

FDA "Warning Letter" to Ft. Dodge

 

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Drug  Recalls - the official explanation

RECALLS - Background and Definitions

(edited with highlights/bold type/italics, for emphasis)

"Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.

A Class I  recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

A Class II  recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

A Class III  recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

A market withdrawal occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.

A medical device safety alert is issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls."

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Other Veterinary Products

CVM Product Safety Information

This page contains "Dear Doctor" letters, and other safety information on products regulated by the FDA Center for Veterinary Medicine (CVM) and other FDA components.

 

 

Copyright 1995 Helen L. McKinnon All Rights Reserved

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