Animals In Print
The On-Line Newsletter
From 4 July 2004 Issue
ProHeart 6 Being Recalled
Proheart® 6 Recall
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
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.
Lot 367158214, Exp. April 05, and Lot 367158215, Exp. June 05.
Fort Dodge Laboratories, Inc., Fort Dodge, IA, by letters on April 27, 2004. Firm initiated recall is ongoing.
Failing dissolution results for the moxidectin microspheres at the 6-month stability time point.
VOLUME OF PRODUCT IN COMMERCE
Return to Animals in Print 4 July 2004 Issue
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