Source: http://www.dogsadversereactions.com/moxidectin/recall.html
Timestamp: 2015-03-31 15:27:03
Document Index: 499272787

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Recalls 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
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS I
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, packaged in 5- and 10-unit packs 20/5-packs per case and 10/10-packs per case, RX, NADA 141-189. Recall # V-004-5.
All lots within expiry.
Fort Dodge Laboratories Inc, Fort Dodge, IA, by Talk Paper and Press Release on September 3, 2004, by letter on September 7, 8, 15, 17, 2004 and October 19, 2004. Firm initiated recall is ongoing.
FDA requested due to serious health concerns.
U.S.: 17,207/5/20-ml vial packs and 26,364/10/20-ml vial packs; Foreign: 19,971/10-ml vials; 43,357/20-ml vials; 300/5 packs & 80/10 packs.
The Enforcement Report of June 9, 2004 shows Proheart® 6 recall of April 27th has been classified as a 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.
CODE 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.
7,390/5-unit packs.
It started with a message found on a message forum....... the possibility of a recall .......then it was confirmed by the FDA, although hadn't been classified as of that date and letters were faxed as shown below: (re formated to fit your screen)
The one addressed to distribtors (Original Scanned Copy)
<<Address1>>
<<Address2>>
<<City>><<State>><<Postal Code>>
ProHeart 6 (moxidectin) 5-Pack Lots 367158214 and 367158215
Dear Distributor:
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. If you have distributed ProHeart 6 from 5-pack lots 367158214 and 367158215 to a veterinary account, please provide a copy of the attached veterinarian letter and Recall Reply Card to that account. 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.
Michael Miodzik
Associate Director, Pharmaceutical Regulatory Affairs
The one addressed to Veterinarians: (Orignal Scanned Copy) Fort Dodge Animal Health
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.
Proheart Tablet Recall
Moxidection