PROCRIT RECALL!!!!!!!!

NEW YORK | Fri Sep 24, 2010 10:37am EDT

NEW YORK (Reuters) - Amgen Inc and Johnson & Johnson are recalling their Epogen and Procrit anemia treatments because of the potential for barely visible glass flakes in vials containing the injectable medicines.

The contaminated product has the potential to cause serious problems, including dangerous blood clots, Amgen said in a press release announcing the recall. However, Amgen said there had been no complaints that can be directly attributed to the presence of glass. It said certain lots were being voluntarily recalled as a precaution.

The glass flakes result from the interaction of the drug with glass vials over the shelf life of the product, Amgen said,

Amgen manufactures Epogen and Procrit in the United States, where it sells Epogen and J&J's Centocor Ortho Biotech unit distributes Procrit. J&J has been dealing with a rash of recalls for its consumer medicines.

Amgen said the recall is being conducted in cooperation with the U.S. Food and Drug Administration.

The drugs have been blockbuster products for the companies, but their sales and those of other anemia drugs, which boost red blood cells, have fallen sharply in recent years because of concerns over potential heart risks from overly high doses.

Amgen shares rose 0.5 percent to $56.02 in early trading. J&J was up 0.5 percent at $62.14.

(Reporting by Lewis Krauskopf and Ransdell Pierson; Editing by Lisa Von Ahn)

[nygirl7]

I'd suggest speaking to the pharmacy you purchased it at at least....

[Bill1028]

I checked with my study nurse and this is her response:

It was one lot number P114942A. Your current lot numbers don’t match. I will check on the others.

[Trish77]

Oh phew.  Thanks for adding that info, Bill.  I'm far from being on treatment let alone on procrit but considering the implications for those that are, was finding this quite alarming.

Thanks to both nygirl and Bill for posting.

[nygirl7]

Doubtful it impacts anyone on the forum but totally better to double check since it's so scary a concept I figure. After all the Procrit I took I can't imagine hearing about this a few weeks after it came out that would panic me so much - HCV really means OCD sometimes, at least it did to me.

[Bill1028]

It would be nice if they included the lot number so people aren't calling their docs.

I have 10 shots to go and I've taken 165 shots in the last 4 years.  I'm still alive...I think.

[nygirl7]

You beat me bill I only took approx. 138 of them!

[merryBe]

well it just goes to show that investors have lost their senses completely....the biggest selling drug they have gets recall for injecting glass into people...and the stock goes UP!!!

Boy have things ever changed since when I started trading!!
What are those people injecting??? rolleyes

[spectda]

http://www.fda.gov/Safety/Recalls/ucm227202.htm

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties.

Amgen Initiates Voluntary Nationwide Recall of Certain Lots Of Epogen® And Procrit® (Epoetin Alfa)

FOR IMMEDIATE RELEASE - THOUSAND OAKS, Calif. (Sept. 24, 2010) – Amgen (NASDAQ: AMGN) announced today that certain lots of EPOGEN® and PROCRIT® (Epoetin alfa) vials are being voluntarily recalled from specialty distributors, wholesalers, pharmacies and healthcare providers as a precaution. The product that is being recalled may contain extremely thin glass flakes (lamellae) that are barely visible in most cases. The lamellae result from the interaction of the formulation with glass vials over the shelf life of the product.

Evaluations by Amgen and Centocor Ortho Biotech Products, L.P. found a low potential to impact patients who may have received the affected product. The potential serious adverse events resulting from the use of a sterile injectable product with particulates by the intravenous route include embolic, thrombotic and other vascular events (e.g., phlebitis), and by the subcutaneous route include foreign body granuloma, local injection site reactions, and increased immunogenicity. To date, there have been no complaints or adverse events reported which can be directly attributed to the presence of glass lamellae.

The affected product lot numbers and expiration dates are included in the table below and at www.epogen.com and www.procrit.com.


Amgen and Centocor Ortho Biotech Products and their affiliate companies have initiated recall letters and other communication to immediately inform relevant stakeholders, including healthcare professionals, distributors, wholesalers and pharmacies of the voluntary recall. The letters include instructions to return the referenced product to the returned goods service provider.

[spectda]

All the information and the list of lot numbers can be found here

http://www.fda.gov/Safety/Recalls/ucm227202.htm

[spectda]

The vials I took are part of the recall. I was mentioning to my wife that it was tender where I and I had a couple of lumps in the belly where I injected. I thought I hit a bad spot, but never had this issue with neupogen or interferon. I sometimes get red blotches but not lumps under the skin. I called and reported it to the manufacturer.

[child24angel]

OH..jeeeeeeezzzz !!!
Thanks for posting this for everyone NYgirl.

Dave....good article but I would also call your doctor...every one should
always keep a log of every single lot number of anything you inject. Keep it for life.

Hugs
Elaine

[spectda]

Thanks elaine-
i still have the empty vials. I am going to contact the doctor. :-(

Thanks for posting nygirl.

[pj1881]

Funny thing is that if I were concerned about little flakes of glass in my drugs, I probably wouldnt have HCV. Looking back at all the times I was ripped off buying the injectable street drugs over the years.... I imagine I injected far worse!!

[eureka254]

OMG.  Thanks for posting this, Deb!  
I didn't see this until just now, and I picked up 8 vials yesterday!  I had to give hubby a shot last night, and both boxes are on the recall list! :(
I'm gonna depend on the statement that "no complaints or adverse events reported..."
I'm pretty pissed at the pharmacy that the news release came out Friday morning, and I was still given the vials Friday at 6pm.  
Never a dull moment, this treatment, yikes. ~eureka
PS: spectda, thanks for the link to the recall list.

[viaduk]

WOW!!  Thanks for the heads- up.

[positude]

Thank you for the info! Just goes to show you that it's always something.

And thanks for the link, guess I'll go check my lot #'s. :)

~Pos.

[jt57]

all the procrit I have is on the recall list.  (had some leftover from last tx)  but was not out of date...  had to have a transfusion in August.  Did not have to last tx.  D!oes it say that it affects the ability for it to work?  My dr was questioning if I was building up antibodies.  

My pharmacist says no more available until late Nov.  same with epogen!  Does this mean transfusions for everyone?  i know it will me!  I will take a nose dive and am already going down again.  Must have had some that was ok, because i have been in the  9's now for a couple of weeks since the transfusion.  hit 8.4 again once.  What next....

Jean

[evangelin]

All my husbands leftovers were on the list!  
Ev

[IAmTheWalrus]

Wow! This might lead to a shortage for people who need it.

[eureka254]

Although the published information seems to point out that only certain lots may be affected, I'm inclined to think that the recall actually includes all lots since they can't be sure which ones have the glass and which ones don't.  

I've been making inquiries into the situation, and I was both angered and disappointed at what I heard: that Amgen, J&J, as well as the FDA have known about this situation for some time now (almost a year).  It seems to me that they are only now attempting resolution on a priority status.  In the meantime, it does not appear that there is any stock currently available not on the recall list.  Maybe someone will pleasantly surprise me, but I'm not believing it'll do me any good to hold my breath on this one.

[evangelin]

Sorry Eureka...just what you didn't need to deal with right now.
Ev

[jt57]

This is horrible.  And it doesn't affect just us heppers.    But for me, I won't be able to finish without procrit or transfusion.  And I am a rvr this time.  with 17 out of 48 wks to go.  cannot stop now!    

Seems like I would have gotten a call, letter or something about this!  Took my procrit shot, later that day went to my pharmacy to pick up my rx refills.  She told me BCBS would not approve the procrit because of the recall?????   That is how I found out!!!!  And I had just taken a shot from a batch that was on the recall list!!!  I'm angry and concerned.  Maybe just 2 transfusions will get me through the rest of treatment....always something!!!

[spectda]

Is the aranesp not an option. I've mentioned it a couple of times. Is it too expensive to get approval.

[jt57]

I don't know.  I see my hema on wed and my hepa on thurs.  hopefully the two can come up with something.  i am going to mention it.  I would think bcbs would approve it, even iff it is expensive, because it is the only drug that hasn't been recalled!

Thanks,

Jean