Recall

Recall and Field Correction: Action taken by a firm to either remove a product from the market or to conduct a field correction. 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.

Link to FDA report http://www.fda.gov/opacom/Enforce.html

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.

Link to FDA report http://www.fda.gov/bbs/topics/enforce/2004/ENF00851.html

(Response from Fort Dodge regarding a recent recall. Reprinted with permission from the recipient.)

Vials:
Overall, the voluntary recall is for unused product only, which makes
it difficult to determine how much product was still in veterinary
inventory when the recall was initiated. Fort Dodge made a good faith
estimate to the FDA that 15% of the product initially distributed would
be returned.

Recall:
This past March, Fort Dodge received a warning letter from the FDA
regarding issues in the sterile filling area of its Fort Dodge, Iowa,
manufacturing facility. The company initiated a voluntary recall to the
distributor/retail (veterinary) level for several lots of sterile
veterinary pharmaceutical products filled between August 29, 2003, and
January 12, 2004, one of which was the vehicle for ProHeart 6, which is
provided in the same box as the microspheres.

This action was a precautionary measure to address issues cited in the
FDA warning letter. All products included in the voluntary recall met
all specifications and passed all quality control tests established and
approved by the FDA.

Fort Dodge maintains an outstanding track record of manufacturing safe
and efficacious products. The company continues to be committed to
enhancing our existing quality systems to support sustained compliance
with current Good Manufacturing Practices (cGMP), and to ensure our
continued leadership as a provider of innovative pharmaceuticals to the
animal health industry.

Kelly Goss, Communications Manager
Fort Dodge Animal Health
9225 Indian Creek Parkway
Overland Park, Kansas 66210
(913) 664-7276 Office
(913) 206-1687 Cell
(913) 664-7291 Fax