Novolin N (Relion) Precipitant Separating...has this happened to you?

[ozzi]

Hi,
I have been using 23 units of Humulin N in the morning and 23 units of Novolin N (made by Relion and sold at Sam's and WalMart) in the evening for Ozzi. For whatever reason, this is the only combination that works for him. Last week I purchased a vial of Novolin N at Sam's Club, and noticed the next day that the white precipitant had completely separated to the bottom of the vial and left all the clear fluid on top. Having used both Humulin and Novolin they usually are cloudy with a bit of residue on the bottom which mixes when I roll the bottle, but I never had it completely separate. I called the pharmacist and she said to not use it. Since she was awaiting an order and had none in stock, she refunded my money, and I went to WalMart and got a vial. The same thing happened. I spoke with that pharmacist, spoke with both the product safety folks and the pharmacist at Novo Nordisk, and a pharmacist at the FDA. All of them said to not use it. So I went to a different WalMart, got a THIRD vial, and it did the same thing. I noticed that the lot number was the same for all three vials XZF0403, exp 3/2012. I don't know that this isn't effective, but wondered if anyone else has experienced this with either Relion or Humulin.
Thanks,
Kevin

[CraigM]

Re: Novolin N (Relion) Precipitant Separating...has this happened to you?

I just looked at my opened vial of ReliOn-N, same batch as yours (XZF0403, exp 3/2012) and it is exactly as yours: clear on top, cloudy on the bottom. I THINK this is normal and just requires "rolling", but don't know for sure since this is our first vial of ReliOn-N. Seems to be working OK for Annie.

I slowly rock the vial 90 degrees left / 90 degrees right ten times (rotate my wrist), then roll in my palms 10 - 15 times. Seems to mix OK.

Craig & Annie

[eileen]

Re: Novolin N (Relion) Precipitant Separating...has this happened to you?

In the 5 1/2 years that I have used Novolin N (ReliOn) for Mildred there have been countless vials separated to the extent that you describe, settled at the bottom and clear on top.

As Craig explains, a simple roll between the palms 10-15 times will completely mix it together. I have never had a problem with a vial being bad.

I would imagine 'all' of these folks telling you not to use the vial (sight unseen)are simply playing it safe.

Eileen/Mildred

[Patty]

Re: Novolin N (Relion) Precipitant Separating...has this happened to you?

I would imagine 'all' of these folks telling you not to use the vial (sight unseen)are simply playing it safe.

My guess would be the same. Will it mix completely when you roll it?

I've heard that Relion doesn't separate quite as much as Humulin but since I've never had a bottle of Relion I don't know.

My Humulin does separate to that extend and I seem to roll it a lot longer the first time I use it, even checking for small pieces to be sure it completely mixed. But after the first time it mixes easier.

Patty

[ozzi]

Re: Novolin N (Relion) Precipitant Separating...has this happened to you?

Thanks Craig and Eileen!
My gut tells me its okay because it does reconstitute immediately when I mix it by rolling it, and there are no clumps or crystals, etc. on inspection. Because this has been the only vial to date that behaved in this manner, I was concerned enough to make sure it was okay to use, and alarmed when I got the directives not to use it. Novo Nordisk is sending me a new vial via FedEx and have asked me to return the vial I currently have for analysis. Hopefully this batch just has a heavier molecular weight or something which is causing the separation. Again, I'm thinking its okay to use, especially since some of you have experienced this before. I'm just concerned that the pharmacist for the manufacturer can't tell me that!!

[eileen]

Re: Novolin N (Relion) Precipitant Separating...has this happened to you?

Kevin,

Again only guessing, but I would imagine no pharmacist is going to say a vial of insulin in question is alright to use, especially not having seen it. That would be too big of a risk and putting themself in a possible bad situation.

I've had some separate this way while others haven't with no problems from either.

Eileen/Mil