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Author Topic: Hospira, Inc. April 2010 FDA Warning Letter re finished pharmaceuticals violatio  (Read 7116 times)
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3catkidneyfailure
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« on: April 22, 2010, 06:06:35 AM »

My crf cats get Hospira subcutaneous fluids among other things:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm208691.htm

During our January 12 - 19 and January 26 - February 23, 2010 inspection of your pharmaceutical and device manufacturing facilities located at 4285 North Wesleyan Boulevard, Rocky Mount, North Carolina, and at 8484 U.S. Highway 70 West, Clayton, North Carolina, respectively, investigators from the Food and Drug Administration (FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)], in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with, CGMP. ...


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kittylyda
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« Reply #1 on: April 23, 2010, 05:23:21 AM »

I use Hospira subq fluids too.  Should we not use them anymore?
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3catkidneyfailure
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« Reply #2 on: April 23, 2010, 06:34:10 AM »

I don't know, kittylyda. They're not listed in the warning letter, but the amount of contamination sure
sounds bad. I have a call in to my vet. I don't know who else to ask.
My cats are getting NormosolR. What are you using? Can you possible call your vet and ask, too?

"This particulate contamination problem has been a persistent and serious issue at your firm for multiple years. For example, 16 lots of Propofol and Liposyn manufactured in 2007 contained visible particulate contamination. Your firm did not detect the particulate problem until November 2009 when you performed the second annual retain inspections, which were three to nine months overdue. By then, all 16 lots had expired. Further, substandard manufacturing practices led to three recent major recalls. These recalls were initiated due to excessive contamination with particulates (primarily stainless steel) and included 78 lots of Propofol, 121 lots of Liposyn, and 24 lots of Cleviprex. These lots were manufactured at your Clayton facility between January 2008 and February 2010."

If you google emulsion products or emulsion parenteral products, it looks like they're discussing forms of
IV fluids for drug delivery. And that's basically what I think subq's are, although I'm not positive, usually
used for IV purposes. So being polluted with metal particles doesn't sound good.
« Last Edit: April 23, 2010, 06:52:05 AM by 3catkidneyfailure » Logged
3catkidneyfailure
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« Reply #3 on: April 23, 2010, 07:24:10 AM »

See JustMe's post on national recall November 9, 2009:
http://itchmoforums.com/recall-nonpet-food/hospira-nationwide-recall-certain-liposyn-and-propofol-products-t9603.0.html

This FDA safety recall page is not available any more at the FDA website (?):
http://www.fda.gov/Safety/Recalls/ucm189564.htm
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Spartycats
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« Reply #4 on: April 23, 2010, 07:38:19 AM »


This FDA safety recall page is not available any more at the FDA website (?):
http://www.fda.gov/Safety/Recalls/ucm189564.htm

3cat - in the Archive section

http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2009/ucm189564.htm
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Spartycats
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« Reply #5 on: April 23, 2010, 07:44:35 AM »

This might be useful:

http://members.verizon.net/~vze2r6qt/supplies/ndc.htm

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JustMe
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« Reply #6 on: April 23, 2010, 03:36:04 PM »

I use Hospira, too.  Hope the salines aren't involved in this.  sheesh. 
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Mandycat
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« Reply #7 on: April 23, 2010, 04:13:33 PM »

From Spartycats post, I would assume that the Hospira fluids are actually being manufactured by Abbott Labs, so I think they would not be involved in this issue.  Also, the drugs named in the FDA notice are drugs that come in bottles but administered by IV injection or drip.  They are not IV fluids as such.  Since IV fluids are clear, it should be possible to spot any particulate matter in the bag, either floating or settled at the bottom of the bag.  Looking for fluids to be clear before administration is always a good idea.  Hope there are no problems, but think that you all who are using fluids are problably safe.
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3catkidneyfailure
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« Reply #8 on: April 23, 2010, 04:35:25 PM »

Thanks, Mandycat, I hope you all are right. Even my vet is hesitating to express an opinion, and they
use Hospira subq's. But it does look like Hospira does not manufacture the subqs based on Sparty's post.

You'd think that metal parts showing up in your products would prompt replacement or repair of the
faulty manufacturing equipment, wouldn't you, after six freakin' months? I mean if you were at all concerned about patient safety and health.

Sorry, it's just after having to be hypervigilant for three years and question everything to prevent my crf kitties from getting wrong meds, meds they were allergic to, perhaps the wrong diet, the wrong phosphorus blocker, the wrong blood pressure meds from the human pharmacy, you start to get
really, really tired and extremely intolerant of product manufacturers who don't give a darn.
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Spartycats
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« Reply #9 on: April 23, 2010, 04:36:02 PM »

From Spartycats post, I would assume that the Hospira fluids are actually being manufactured by Abbott Labs, so I think they would not be involved in this issue.  Also, the drugs named in the FDA notice are drugs that come in bottles but administered by IV injection or drip.  They are not IV fluids as such.  Since IV fluids are clear, it should be possible to spot any particulate matter in the bag, either floating or settled at the bottom of the bag.  Looking for fluids to be clear before administration is always a good idea.  Hope there are no problems, but think that you all who are using fluids are problably safe.

Sorry-- don't know how dated my source is - Hospira "spun off" from Abbott (2004)- so they are manufacturing.   Agree with everything Mandycat said about fluids.  Do wish all would get their act together, as far as GMP.

http://www.abbott.com/global/url/content/en_US/70.30.100:100/general_content/General_Content_00101.htm
« Last Edit: April 23, 2010, 04:38:51 PM by Spartycats » Logged
3catkidneyfailure
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« Reply #10 on: April 23, 2010, 04:43:26 PM »

What do I do? Flip a coin about a temporary change at this late stage of renal disease until this
falls out, or keep on going with Hospira? That seems to be the options. And my kids are in precarious
positions both.
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Spartycats
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« Reply #11 on: April 23, 2010, 05:01:19 PM »

What do I do? Flip a coin about a temporary change at this late stage of renal disease until this
falls out, or keep on going with Hospira? That seems to be the options. And my kids are in precarious
positions both.

3cat, I would ask your vet - maybe have him/her look at the fluids?  If this doesn't involve that product, I wouldn't want to put them through a change, from what is working for them.
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Mandycat
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« Reply #12 on: April 23, 2010, 05:02:54 PM »

3cat,
The decision is yours to make, but I would not make any changes. There is no indication that IV fluids are involved in any way, and, since Hospira is a very, very large company, there are probably mulitiple sites where various products are produced.  I would also suspect that the process for producing bags of IV fluids is in no way the same as producing bottles of other kinds of drugs.  A problem with one type of product does not automatically mean that all products will have problems.    
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3catkidneyfailure
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« Reply #13 on: April 23, 2010, 05:32:53 PM »

I appreciate the advice and invite others in this position with their pets to offer their opinions, too. And then
each of us will have to decide unless more news comes up.
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kittylyda
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« Reply #14 on: April 23, 2010, 06:47:47 PM »

I don't know, kittylyda. They're not listed in the warning letter, but the amount of contamination sure
sounds bad. I have a call in to my vet. I don't know who else to ask.
My cats are getting NormosolR. What are you using? Can you possible call your vet and ask, too?

3cat, I don't know what NormsolR is.  As far as I can tell from looking at the bag, what I use is straight up lactated ringers.  I have used Baxter's lactated ringers in the past once or twice, but I would probably have to search around to find that on line.  All my vet will say is that they have not heard about any problems or recalls with the fluids.  At this point I guess we would have to assume the fluids are unaffected.  Veterinary offices use tons of this stuff so I would assume that they would be aware of any adverse effects at this point?  At least I hope they would.
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