Amaze
06-13-2004, 09:33 PM
Hi guys-just got this email from my kennel club about a Proheart recall...Check your pills if you use it!
Lys
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.
Sincerely,
Michael Miodzik
Associate Director, Pharmaceutical Regulatory Affairs
Lys
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.
Sincerely,
Michael Miodzik
Associate Director, Pharmaceutical Regulatory Affairs