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Author Topic: Problems with J & J/Merck Plant-Probable Product Shortages  (Read 12945 times)
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menusux
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« on: July 19, 2010, 12:37:41 PM »

http://www.baltimoresun.com/business/sns-johnson-johnson,0,5640902.story

Baltimore Sun July 19, 2010

FDA cites plant that makes Pepcid, Mylanta, Mylicon

"In a fresh blow to its manufacturing operations, Johnson & Johnson has been cited by U.S. regulators for problems at a plant that is part of a consumer medicines joint venture with Merck & Co.

"J & J confirmed Monday that Johnson & Johnson/Merck Consumer Pharmaceuticals Co had received a "Form 483" report from the Food and Drug Administration after the agency's recent inspection of a plant in Lancaster, Pa. A Form 483 report lists any problems found during an inspection.


"A Merck spokeswoman declined to make an additional comment. An FDA spokeswoman confirmed the agency had issued the inspection report but said it was not available.

"The inspection report for the Lancaster facility comes as J & J is trying to fix problems at another Pennsylvania consumer products plant, where it has halted production after a recall of a raft of children's medicines.

"The J & J/Merck joint venture was formed to market nonprescription drugs derived primarily from Merck. Its products include the heartburn medicines Pepcid and Mylanta, and the Mylicon infant anti-gas drops.

"The Lancaster facility is jointly owned by the companies but managed by J & J.


"In November 2008, the joint venture recalled 12,000 bottles of Mylicon because they might have contained metal fragments.

"J & J has issued four major recalls of its consumer medicines in the last year, tarnishing its reputation and sparking an investigation by U.S. lawmakers. One of the biggest recalls was April 30, when J&J took 40 widely used children's medications off the market, including painkillers Tylenol and Motrin and allergy treatments Benadryl and Zyrtec.

"The Fort Washington, Pa., plant where those medicines were produced was closed after FDA inspectors said they found thick dust, grime and contaminated ingredients. J & J said last week it would revamp the plant and eliminate 300 of its employees.

"J & J has said most of the products made in Fort Washington are unlikely to be available before the end of the year."
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JJ
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« Reply #1 on: July 19, 2010, 06:30:16 PM »

Awww shucks, get caught with dirty environments (especially w/production and manufacturing of medicines that are inanimate objects) so whatever goes into them does not get digested/broken down any further. The product is final, complete and now made in dirty facilities? Now they are crying woe is me? Laws are laws for those that break 'em you gotta abide.
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3catkidneyfailure
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« Reply #2 on: July 19, 2010, 06:43:55 PM »

Ah bloody heck, my chronic renal failure kitties get Pepcid AC original strength every day.
I bet lots of cats on here do. Any further information on this will be much appreciated.
Pretty much any day without this Pepcid and I can guarantee I'm going to see vomitting
in some form.
« Last Edit: July 19, 2010, 06:46:41 PM by 3catkidneyfailure » Logged
JJ
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« Reply #3 on: July 19, 2010, 07:08:38 PM »

3cats I wish I had older dated to send to you. Will see if my friend has any left of the last time I got him a bottle if he is not using it anymore and get it for you. This has got to be awful for thousands and thousands of people out there.
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3catkidneyfailure
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« Reply #4 on: July 19, 2010, 07:13:27 PM »

Thank you, JJ, very much for very kind offer. I believe there is an effective dose of Zantac
for cats, but I don't remember what it is or who makes it.

http://www.zantac75.ca/en/what_is_heartburn.asp
McNeil Consumer Healthcare Division of McNeil PDI Inc. is the maker of ZANTACĀ® 75, Canada's #1 Doctor recommended acid reducer, we know that medication is only one of the possible ways for dealing with heartburn and acid indigestion.

Has anyone used Zantac instead of Pepcid AC for chronic renal failure cat? Would double check any information with my treating vet, of course.

« Last Edit: July 19, 2010, 07:19:32 PM by 3catkidneyfailure » Logged
menusux
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« Reply #5 on: July 19, 2010, 07:22:39 PM »

3 cat-

From what's been said, it looks like only the products recalled made in Fort Washington, PA are going to be hard to get. 

"J & J has said most of the products made in Fort Washington are unlikely to be available before the end of the year."

The Pepcid and others come from a jointly owner J & J/Merck plant in Lancaster, PA.

"J & J confirmed Monday that Johnson & Johnson/Merck Consumer Pharmaceuticals Co had received a "Form 483" report from the Food and Drug Administration after the agency's recent inspection of a plant in Lancaster, Pa. A Form 483 report lists any problems found during an inspection.

http://www.fda.gov/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/default.htm

This is the place where the 483 will eventually be posted; scroll down the list and you'll see a lot of old "friends" there-from the Peanut Corporation of America to Diamond to two for Teva-their Animal Health facility and their injectables (parenteral) plant where the defective propofol came from.
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mainecoonpeg
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« Reply #6 on: July 19, 2010, 07:26:11 PM »

3cats, my vet recommends ZANTAC/RANITIDINE over using Pepcid.

She finds it more effective at a lesser dose than the Pepcid.

She is on vacation until July 29th.  I have an appointment on July 30 and will have her go into more specifics if you want me to.  She may even have literature that you might be able to present to your vet along with my vet's findings.
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3catkidneyfailure
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« Reply #7 on: July 19, 2010, 07:31:59 PM »

Thank you so much, menusux, for pointing that out, that it's unlikely to cause a Pepcid shortage. But at this point, given J&J's increasingly checkered over-the-counter production history, if there's a switch possible, I'm probably going to consider it carefully. My kids are
getting down to the wire and don't need any J&J filth problems in my opinion at this point.

Peg, you darling, yes, anything you can find would be great. I did a quick search, and sure enough it was Kafee:
http://itchmoforums.com/feline-chronic-renal-failure-and-insufficiency/anyone-using-famotidine-t5999.0.html;msg85293#msg85293
who says one eighth of a Zantac 75, which I would of course confirm with veterinarian, too.

So it sounds like one way or another, there is a possible solution here.
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mainecoonpeg
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« Reply #8 on: July 19, 2010, 07:38:19 PM »

3cat, I read through the link and Mandycat had posted some very valuable information about B12 depletion.  My vet recommends B12 injections for kitties who are on Zantac or Pepcid for longer than 6 weeks.

I will call over tomorrow.  I'm pretty sure the head tech is working and I'll ask her for some info for you to ask your vet about.
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3catkidneyfailure
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« Reply #9 on: July 19, 2010, 07:56:14 PM »

Thank you, Peg, very much.
Another good past thread if you might be worried about Pepcid AC also:

http://itchmoforums.com/feline-chronic-renal-failure-and-insufficiency/anyone-using-famotidine-t5999.0.html;msg88026#msg88026re is a really good web page regarding controlling stomach acid with CRF:
http://www.felinecrf.org/treatments.htm#controlling_stomach_acid
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lesliek
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« Reply #10 on: July 19, 2010, 08:15:04 PM »

3cat- Remy was originally on Zantac75 & the pill dosage was 1/8 to 1/10 [he weighs 13.5 now-1/8] but when he was sick was slightly under 12 lbs [1/10]. We did try the liquid which worked better but tasted nasty. Its rx only & his dosage at 12 lbs was 0.35 ml by mouth or in food twice daily. He is a dog & not kidney issues, but liver problems, so double check those dosages with your vet. Although there is no warning to refridgerate the liquid,my pharmacist suggested it would help keep it fresh with the small dosage amount.The rx name is Ranitidine syrup.
ETA I have about 2 doses left [1 1/2 yrs old,but refridgerated] & can send it if you want to try it before filling a prescription.
« Last Edit: July 19, 2010, 08:16:59 PM by lesliek » Logged

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catmom5
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« Reply #11 on: July 20, 2010, 04:03:33 AM »

CJ has used Zantac in the past (she's currently on Pepcid). She took 1/4 of a Zantac 75 caplet morning and night. Sometimes it just seems that one is not as effective so I switch back to the other. She has done very well on both, actually.
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JJ
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« Reply #12 on: July 21, 2010, 04:13:36 PM »

Johnson & Johnson says it's been subpoenaed by a federal grand jury and is cooperating in an investigation into the series of high-profile recalls of its consumer drugs.

http://www.fiercepharma.com/story/j-j-cuts-forecast-discloses-grand-jury-probe/2010-07-20
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3catkidneyfailure
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« Reply #13 on: July 21, 2010, 06:09:01 PM »

Hey, thanks, JJ. Your link says:

including lawsuits against its McNeil Consumer Healthcare unit and ongoing government probes, CNN Money reports

So J&J makes Pepcid AC original strength.
And McNeil Consumer Healthcare makes Zantac.

Looks like it doesn't matter. It's a J&J product we're all using for acid blockers on kitties.

Anyone tried to use slippery elm on renal failure cats in Stage 3 and care to comment?

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lesliek
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Trooper,Remy & Fragile


« Reply #14 on: July 21, 2010, 06:26:01 PM »

Looks like we will all be buying generics made in India or China. I wonder if any of the new acid block/reduce drugs are safe for cats & dogs ?
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