Animals In Print
The On-Line Newsletter

From 4 July 2004 Issue

ProHeart 6 Being Recalled

http://www.dogsadversereactions.com/moxidectin/recall.html

Proheart® 6 Recall 

http://www.fda.gov/bbs/topics/enforce/2004/ENF00851.html

The FDA states: "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."

The Enforcement Report of June 9, 2004 shows Proheart® 6 recall of April 27th has been classified as a Class II..

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
_______________________________
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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