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 November 24, 2004 shows Proheart® 6 recall of September 3rd, 2004 has been classified as a Class I

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

The one addressed to Veterinarians: (Orignal Scanned Copy)

Fort Dodge Animal Health
Division of Wyeth
500 5th Street NW
Fort Dodge, IA 50501

P.O.Box 518
Fort Dodge, IA 50501

April 27, 2004
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ProHeart 6 (moxidectin) 5-Pack Lots 367158214 and 367158215

Dear Veterinarian:

Fort Dodge Animal Health is initiating a voluntary recall of ProHeart 6 (moxidectin) 5-pack lots 367158214 and 367158215. These 5-pack lots are being recalled due to dissolution results that were out of specification during routine six month stability testing. The dissolution test includes five time points (1, 1.5, 2, 2.5, and 4 hours), and the results at the 2 and 2.5 hour time points were slower than approved criteria.

ProHeart 6 5-pack lots 367158214 and 367158215 were manufactured by Fort Dodge Animal Health in June 2003, packaged in 5-unit packs of 598 mg vials of moxidectin microspheres and 17 ml vials of vehicle and distributed by Fort Dodge Animal Health from July 2003 to January 2004.

Please note this recall applies only to unused product. If you have already dispensed Fort Dodge Animal Health is initiating a voluntary recall of ProHeart 6 5-pack lots 367158214 and 367158215, no further action is necessary. If you have ProHeart 6 5-pack lots 367158214 and 367158215 in your inventory, please refer to the directions for product return. Please note that this recall only applies to ProHeart 6 5-pack lots 367158214 and 369158215. No other lots of ProHeart 6 are affected by this recall.

Directions for Product Recall and Return:

1. Examine your stock immediately to determine if you have any ProHeart 6 5-pack lots 367158214 and 367158215. If so, discontinue sales of these lots and place the inventory in a secure location.

2. Determine the quantity of ProHeart 6 5-pack lots 367158214 and 367158215 in your possession and record on the enclosed Recall Reply Card. Please indicated on the Recall Reply Card if you have sold ProHeart 6 5-pack lots 367158214 and 367158215 to any veterinary accounts and forwarded the recall information to those accounts., Please return the Recall Reply Card separately; do not mail it with the returned product.

It is important that you complete and return the Recall Reply Card even if you do not have ProHeart 6 5-pack lots 367158214 and 367158215 in your inventory.

3. Please contact Joyce Moretz, Customer Service at 800-677-3728 to arrange return shipment to Fort Dodge Animal Health. Customer Service can answer any questions you may have regarding the return procedures.

We will issue your choice of replacement product or credit as soon as your return is received.

This recall is being made with the knowledge of the United States Food and Drug Administration. We appreciate your assistance and apologize for any inconvenience.

Sincerely,

Michael Miodzik
Associate Director, Pharmaceutical Regulatory Affairs