Procrit and Epogen Recall Issued Over Glass Flakes in Vials

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A recall of Epogen and Procrit vials has been issued due to a risk that certain lots of the anemia drugs may be contaminated with small glass flakes that could be injected into patients. 

The FDA announced the Procrit and Epogen recall on Friday after Amgen discovered extremely thin glass flakes, called lamellae, in some vials of the drugs. While evaluations by Amgen and Centocor Ortho Biotech Products, L.P. determined there to be a low potential impact to patients, there is still a chance that the flakes, which are barely visible, could negatively impact the immune system, cause embolic events, blood clots, or damage veins as well as stimulate injection site reactions.

The glass flakes are believed to have been caused by interaction between the drugs and the glass vials over time. So far there have been no reports of injury or negative reactions from recalled Epogen and Procrit.

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The Epogen and Procrit recall affects about 200 lots total for both drugs. The entire list is available in the Amgen recall press release.

Epogen (Epoetin alfa) and Procrit (Epoetin alfa) are prescribed to patients with kidney disease, anemia, HIV and cancer to stimulate bones to increase the production of red blood cells. They are also prescribed to patients preparing to undergo major non-heart surgery to reduce the number of transfusions such patients must receive. Amgen manufactures both drugs, though Procrit is sold and marketed by Johnson and Johnson.

A number of prior studies have suggested that the drugs may increase the risks of heart attack, strokes, blood clots and death, causing sales to drop in recent years. In 2007, the FDA issued a public health advisory regarding the drugs, saying that side effects of the Anemia drugs could increase the risk of injury or death at high doses. The FDA required that the drug makers add a “black box warning” alerting patients to the risk of blood clots, strokes, heart attacks and death. The black box warning is the strongest label warning the FDA can require of a medication.

In February, the FDA announced that it was restricting the prescription of the anemia drugs under a risk evaluation and mitigation strategy (REMS). Doctors and hospitals that wish to prescribe the drugs will now have to undergo special training to identify high risk users and negative side effects.  Cancer patients using the drugs are of special concern, because some studies indicate that ESAs can stimulate tumor growth. Amgen is required to oversee hospitals and doctors using the drugs as part of a cancer treatment program to ensure they are compliant with all aspects of the REMS.

Tags: Anemia, Anemia Drug, Blood Clot, Drug Recall, Epoetin Alfa, Epogen, Johnson and Johnson, Procrit
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18 Comments

Judy
Has anyone or does anyone know how or if it is dangerous now my uncle has been prescribed it
Justine
I was being treated for hep c, & was put on procrit. I also ended up with recalled bottles for shards of glass. They burned going in & I was experiencing heart palpations,dizziness,problems walking. I found out through my caremark provider about the recall ONLY when I called for a refill. I was getting 1 month supply at a time. I had already taken 3 of the 4 bottles. I then called my Dr. who didn’t even know about the recall at that time. I had to inform MY DR.? When I went in to see her, I was told the worse that could happen would be I could have them work themselves back out, like a sliver would. Well I have to take alot of injections in my stomach, some for other health issues. I still to this day have “slivers” of glass working there way out. They may be tiny, but when you feel them coming out, you know what it is. I have been able to use tweezers to remove, cannot really see it well but under a magnifying glass, you can tell. Also when they are right under the skin coming out I can feel it. Why isn’t there a lawsuit for this? Why was the company so slow to inform anyone?
Amy
i received this glass contaminated methotrexate injection, 24 hours later i was on life support for nearly 3 mo. not one doctor could tell my husband why or what happened. a month after i finally made it home. I received a certified letter stating i received this recalled med. When i brought it to the dr’s attention his immediate response was “I won’t even consider it.” After a careful review of the medical records i found that i had experianced every side effect the press release said was possible. nothing you could fake. this was all internal bleeding, damage to organs swelling, philibitis, thrombosis. just to name a few. we hired a law firm that informed us because there was no other established publications on this injury. we would not be able to persue any further. They did admit they felt the med. to be responsible. but due to no previous cases. we could not file one either. Has anyone ever heard of such a thing.
Richard
I have been on Procrit for several years. From late 2009 to 2010 I had several injections that burned like never, ever before!! OMG, they burned. My arm felt like it was going to depart at the shoulder on one occasion directly after my injection. I told my nurse every time my injections burned so badly. She didn’t say a thing. Now, early this year I received the notice from Johnson and Johnson/ Stericycle explaining there is a recall and why the recall was issued. I continue to get procrit injections but the last 6 injections have not burned like the ones I received in 2009 and 2010. I have done some extensive research on this problem but never really worried about it that much. If you were to receive injections subQ (just under the skin) from one of the contaminated amps/vials I would be willing to be that the worst you would notice would be the more than normal burning sensation at the injection site and pain there for a few days. I never ran a fever or suffered any other problems, so I never gave it allot of credence. NOW, if you were to receive it I.V. it could possibly cause more problems and need to be monitored by your doctor, medical professional. Either way, It is good that they issued the recall and actually could have not recalled it if you were receiving it subQ and only recalled the lot #’s if it was to be given I.V. I think procrit is a very good pharmaceutical and they are not forced to give it to anyone. I give them credit for going above and beyond for even offering this pharmaceutical to give us my energy. I remember when two members of my family passed away to Renal failure and had zero energy. I can only wish they had procrit when my two family members were in Renal Failure and had to go through it without the help of Procrit/Epogen. Their quality of life would have been much better than it was due to not having either of the aforementioned drugs available to them many years ago. If you are still alive, you are going to be fine from now on with Procrit or Epogen, as long as you don’t let your Hemoglobin/Hematocrit get too high. Best of Luck to you all, Richard
Misty
I was on procrit last year for approx. 8 months. After I finished the treatment, I received a letter delivered from Fed Ex explaining that the procrit I had received was the lot numbers that matched the ones that were found to have shards of glass and should return it immediately. I contacted them and also the home health company I had received it from. The procrit hotline sounded very intense on returning it immediately and after explaining I had already taken all of it, then there was suddenly no issues. The home health company said the only side effects I could’ve gotten from the glass was skin irritation and to continue sending payments. I still have an outstanding balance of 2400.00 that I pay 50.00 /month. I had to have two surgeries also last year and can only afford to pay 50.00 to each one plus 50.00 to the surgeron where my son also had surgery last year. I honestly don’t feel right that I have to pay this amount back since it would’ve been recalled and replaced anyways and also that I was not informed of all of the side effects it can cause. Before I started treatment, I weighed 120 lbs; since I have completed treatment, I currently weigh 101 lbs and feel awful all the time. I even take weight gainer to try and gain weight. I was on procrit because after seeing a dr. for severe joint pain, I was diagnosed with Hep. C. I went through 8 months of strong meds that as of last week have still had my blood work come back as no viral count and free of the hep. C. I had to take the procrit because the strong meds were making my blood cell count so low it was becoming very dangerous. Any thoughts on if I should have to pay this recalled drug back or if I should see someone about my current symptoms? Thank you and have a Blessed day!
TONI
MY HUSBAND DIED 2 DAYS AFTER RECIEVING EPOGEN AT DIALISIS WHICH WAS FROM A RECALLED VIAL HE ALSO HAD SHORTNESS OF BREATH AND OTHER SYSTOMS RELATED TO EPOGEN.
elizabeth
I have recently experienced numbness in my legs and feet,and its only getting worse. cannot get any answers.WHY does any healthcare professionel/FDA care?
Dwain
I too have been taking this stuff from the bad lot numbers and today they call me to get them back. today is 12/06/2010. This stuff has been bad since Sept this year Why is it still going on this is my second recall of this stuff but the first time I’ve ever had felt bad alot of muscle spasms and trouble breathing. I THINK IT”S TIME FOR LAWYERS !! May the abused unite and fight for whats right !! I think I’ll save a bottle for a lawyer
dolores
This is insane! I went for my 6 wk. procrit shot today and was told there was a recall. No explanation, nothing. I looked it up on inter-net. You would think dr.’s office would tell people the truth and warn them to be aware of problems. Don’t we get these shots because we already have problems? What a mess the medical field is anyway. And yes, I do have a lot of questions about Procrit. Please post more.
Steve
I posted last week and I am postig again. I just called the procrit recall line again and gotno firther than last time. they have no idea what is going on. I am still having symptoms. I feel like my hads are tied.
commentsby Sandra
I received 40,000 Units/mL twice a week I been on this dose for a long time. I eperienced some very sharp pain and I noticed a rash that look swollen and red, after taking the dose on Sept27th, Sept 30th, Oct 4th Oct 7th was feeling some dizziness and heart palpitations is there someone who know when this glass thing started. And what can we do ?you ask questions no one wants to tell you the true about this PROCRIT EPOETIN ALFA MY LOT GO49110A PHARMACIST TOLD IT WAS ONE OF THE RECALL MED.
Marsha
This is extremely frightening! How long has this been going on?? My mother was a cancer patient who was doing very well on chemo. She had recently had scans that looked very good and the oncologist told her he could probably give her quite a few years! He had had similar patients that had survived 10 to 15 years or more! She received Procrit through her port on several occasions with the last one being extremely painful and grueling. She constantly complained about the palpitations, numbness, difficulty walking, dizziness, and nose bleeds and was told that most people who get chemo have this. Then on June 12, 2010 these symptoms became so bad that she begged to go to the hospital. They found clots everywhere and said that the cancer had just spread like crazy. The clots became so bad that she had emboli all over the place. She couldn’t breathe or anything and over the course of a few days she was gone. She was only 66 years old. I would hate to think that this drug had anything to do with her mortality!
Steve
Wow, I can’t believe this! I had no idea that there were these risks and now this glass thing! To Anthony and others, the last 2-3 times I took it, it burned like heck, and I never had that before! I kind of ingored it! I also have heart palpitations, dizziness. My arm also blew up like never before. What can we do?
JR
2 injections weekly, some from recalled lot.
Thomas
I have received 20 injections of procrip trying to raise my hemoglobin from 8.9 to 10.5 so I could undergo rmoval of a cancerous kidney. Weekly checks showed the hemoglobin varying up and down and today is 9.1 Obviouantly there is something else wrong.
anthony
I went to pick up my Procrit on 9-17 and was told that it was back ordered then again on 9-24 told the same finally today I was told by my Pharmacy it was being recalled. I Already took 3 Injections with the lot being recalled. I noticed the shards in two of them but never suspected this as glass, It hurt bad going in not something I ever experienced in the past. Scarry, I hope its all Ok for Me. Good Luck with Taking it Unfortently I need it for my mds but it is now not avilable, No Notices about it from anyone including my Pharmacy, FDA, or the Media, How Sad, none of them Care about the Public
Ron
How come this has not been on Fox news ? It is time to watch quallity control.
James
I just recieved a call from Wake Dialysis Clinic in Raleigh NC and I was ask to give the lot number on the remaining Epogen bottles in my possestion. After I gave the prosiding nurse my lot number which is 1015501 she told me to isolate those remaining four bottles and bring them back when I come for my regular visit on October 1st 2010. I have been having some strange occurances of unexplained noise bleeds and skin brake outs in my head, arms, stomach at site injection locations, continuus heart pulse over 110, numness and cramps in both hands and feet. I’ve informed my Doctor if these complaints and they’ve not given me any satisfactory explination for them.

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