URGENT - Recall of Prep Pads

[Lulu54]

The NMSS has posted a link to the FDA recall website - Triad Alcohol Prep Pads, Swabs and other assorted items for prepping before injections have been recalled.  I just checked and these are the wipes I get with my Copaxone.  I'm not sure what the other injectibles send for site prep.

It is unclear if this applies to the ones supplied to me, but if the NMSS felt it necessary to post this warning, it is worth sharing with you.  

From the FDA site:

"ISSUE: Triad Group, a manufacturer of over-the-counter products and FDA notified healthcare professionals and patients of the recall involving all lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad but sold as private labels at the consumer level. This recall has been initiated due to concerns about potential contamination of the products with Bacillus cereus. This recall involves those products marked as STERILE as well as non-sterile products. Use of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients."



http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm

[jean_619]

Wow.  This is so weird.  I only just heard about the recall because I'm on the FDA recall email list.  FYI:  I'm not paranoid, I'm just on the recall email list because I used to work in the product safety field and I needed to know that type of information.  =)  

Anyway, that recall notice didn't say anything about Copaxone (which is what I'm on), and Shared Solutions hasn't called me or left me any kind of message or sent a letter.

That's irritating.

Sorry I just posted a new message in the forum about this.  I searched for Extavia in the forum and nothing came up in the results regarding the recall.  

Jean

[jujuminx]

I got automated call yesterday from Prescription Solutions regarding refilling my copaxone. When I called back to refill, I asked them about the recall. Rep told me she and other reps just got email on it that morning and were told to refer all inquires to pharmacist. She didn't have any info other than if questioned to transfer calls.  No pharmacist on duty so told me to call back today.

Pharmacist today said they just got email yesterday regarding recall. Said it's consumer level, not class 1 recall. Meaning the risk is deemed low and they are not required to call their customers. Only one reported case of skin infection from potentially contaminated wipes.  PS says it effects about 7K of their customers and they are currently negotiating with manufacturer regarding compensation for lost product. All PS customers will be getting letter regarding recall.  

They are sending me two boxes of replacement wipes along with copaxone.

Julie

[twopack]

I just now received a call with a recorded message from Shared Solutions/Teva saying to discard Triad alcohol swabs that come packed in the box with Copaxone but to continue using the Copaxone, prepping with bottled or single use alcohol wipes available for purchase at your local drugstore.

It's about time.

Mary

[meg321]

I just reordered my copaxone yesterday from Aetna specialty  and they did not know, they asked i of I needed them and I told them about the recall, they had not heard about it.  

Maybe by now they have...

meg

[cainer]

thanks lulu-  just got e-mail from them not to use them--  it took them awhile-  but im not complaining- they have been great!!!

[Lulu54]

I just got an email from Shared Solutions marked important information,  telling me to not use these pads.  This is almost 48 hours after I posted this on the forum .... Makes you wonder who should be working their communications department for SS.  I could use a third job!  

At least they are now getting the word out - albeit a bit slow.

[sllowe]

Ut oh, have to go check my brand. I get mine from pharmacy w/my re-fills when I need them.

Thanks for this, Lu!

[twopack]

I just got a phone call from Shared Solutions in response to my email.  They told me they are telling people to dispose of TRIAD alcohol prep pads that come with Copaxone.  They didn't seem to have a plan to initiate contact with Copaxone users.  They just said, "We've been telling people......."  Maybe they think it's up to the FDA.

They also mentioned a customer who "hated to waste them" and told me I could use them for other household uses (like stain removal) or crafts (like ?).  They were specific only that they not be used on skin, open areas and for injections.

So what about my dry chapped hands as I hold them for household jobs?  Do I wear gloves?  I realize the risk is very small but I have no guilty green conscience on this one.  THEY ARE ALREADY TRASHED.  I just wanted to hear Shared Solutions/TEVA show SOME concern for their customers.


SS is like the girl with the curl.  When they are good, they are very very good.  When they are bad, they are horrid!  JMO

Mary

[twopack]

Thanks Lulu.  The Copaxone site had nothing that I could see.  I sent them a message asking for info and giving my opinion on their silence.  Can't believe they are unaware.

Mary

[LATW]

interesting.  I recieved this brand of prep pad with my Betaseron and had a nasty infection in an injection site.

it took several rounds of antibiotic to clear it up.  This was this summer while I was using Beta.

LA

[Lulu54]

I've asked the moderators to tack this for a week or so to keep it visible - good suggestion!

[cainer]

bump

[twopack]

I wonder if this infomation could be thumbnailed at the top for a little while so members who aren't here on a daily basis have a better chance of seeing it.  At the moment, we are in the middle of one of our weekend slowdowns of people traffic.  

Since Shared Solutions isn't getting info to us, I'd hate for this to get scrolled to page two before people read it.  I do think I'll stroll over to the SS/Copaxone site and see if they mention this.

Thanks again Lulu,
Mary

[Pfurs]

Thanks for the post. I'm surprised shared solutions didn't call me. They call for everything else. I tossed. Everything that I had as it was made by triad.  Thanks again

[twopack]

I wondered at that myself Lu.  It seems this bacteria is one that can form endospores which allow it to survive poor environments by taking on a dormant form.  It is a type of bug that is associated with food poisoning type symptoms like nausea, vomiting and diarrhea.  Sounds like the one reported case was a skin infection though.

All mine are trashed now.  Thanks for the info.  Nobody else seems to be in a hurry to let me know.

Mary

[Lulu54]

I can't figure for the life of me how any microorganism can live in alcohol ....   as I originally posted I'm not positive that this applies to the TRIAD labeled pads but if NMSS says don't use them, I'm following their advice.  

[anon07072023]

Oh, Geez! Thank so much for the info Lu!  I have them, too!!!
I have some other brand I had bought to clean the auto-injector.  It looks like I'll be using those starting tonight!

[wiggles94]

Thanks for this information Lulu!  I have been using these for a year - no problems - but I guess I need to get rid of them anyway!
Carol

[COBOB]

Guess I lucked out.  The ones that came with the Copaxone were in the recall, but I had the specialty pharmacy send me an extra box that turned out not to be from Triad.

[jujuminx]

Yikes!!!  Throwing mine out now and heading to the store for more.  Not going to CVS or Walgreens.

Thank you soo much for posting Lulu.

Julie

[meg321]

I read everything but it doesn't say how long this contamination has been out there...and what kind of symptoms are we looking for?

meg

[meg321]

Just dumped mine...and will read the links..

meg

[Sumanadevii]

I would hope they have something to say and quickly get the word out.  It is all we need...infections!!!

[MCBCON]

I have been using them seeing as it was sent via Copaxone.  I would hope they have something to say.