Batches of ProHeart6 recalled!

[ramanth]

This made my day.

http://www.dogsadversereactions.com/...in/recall.html

Proheart AE 6 Recall

http://www.fda.gov/bbs/topics/enforc.../ENF00851.html

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 AE 6 recall of April 27th has been classified as a Class II..

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.
~~~~~~~

Kia got the shot June 2003, so it was not this batch...however...if this batch was bad...how many others could of been?!?

[RobiLee]

Kim, I'm so glad that you warned me about this. I owe you a big THANK YOU. Katie did have one shot without side effects but after hearing Kia's story. We switched to the chewables and when we took Tori for her checkup and shots. I quickly informed the vet that I want the chewables.

Thank you, Thank you, Thank you!!!

{{{HUGS}}}....Robin

[Logan]

Sounds like it is just a specific lot #, Kimmy, not the product. But I guess it is a start.

[ramanth]

You're welcome.

You're right Logan. The FDA's big words can get to me. And too bad it wasn't a Class I recall, but I'll take what I can get.

[Logan]

Amen to that, Kimmy!!!

[Cinder & Smoke]

Some personal observations about the ProHeart 6 "Recall"...

Fort Dodge doesn't exactly *say* what, if any, "effect" the
product failure HAS on treated dogs.

The Ft Dodge Letter to VETS just tells them to Not Sell any MORE
doses of the recalled product -
doesn't say or suggest a thing to do for or with dogs who
already Received a dose from the recalled lots.

The Wyeth / Fort Dodge Animal Health / ProHeart 6 "Gang" have
added several pages the their PH6 web site -
Seems like Damage Control to me...

Wyeth / Fort Dodge PH6 product page
with a *link* to the proheart6.com page >>

www.proheart6.com

The proheart6.com page has a *click link* titled
"ProHeart 6 In the News" -
which gets you to a "Rumor Letter" addressed to
"Dear Dog Owner".

"ProHeart 6 In the News"

The "In the News" ("Rumor Letter") has two links to *questions & answers*
that Fort Dodge claims to have sent to the Boston and Chicago
news media who had broadcasts critical of PH6.
Here's those two "Q&A" links >>>

Q&A to CBS - Boston and
Q&A to CBS - Chicago

Bottom Line...?

Wyeth / Fort Dodge certainly is NOT admitting that their ProHeart 6
product is either Questionable nor Unsafe.

Even the FDA hasn't really said anything "bad" about the product.

There's been enough warnings for ME -
Cinder & Smokey will NEVER see a PH6 shot!

And even if you have a dog (Collie-types) who shouldn't use
some of the "other" heartworm preventatives like our current
Heartgard Plus -
I'd strongly suggest you and your Vet pick anything
except ProHeart 6 to protect your dog!!

/s/ Phred