Possible Ultrase enzyme problem specific lot number - Cystic Fibrosis Message Board

sherry092 · 11-15-2005, 07:18 PM

My 3y/o DS has been on Ultrase for quite a long time. We use 2.5 caps on a spoonful of applesauce. I say this because not everyone on enzymes opens their capsules and sees whats inside.

I got a refill on our perscription, and when I opened the capsule, the contents did not look like it usually does. Instead of being these round, off white, spheres-- these were brown, shrunken, and left a white residue in my hand. I called Axcan and informed them & was asked to send some of my capsules. They have not reponded to me.

I brought them to my CF nutrionist & she did not like the looks of them at all. They are time released and their coating needs to be in tact. She contacted Axcan and they have not responded to her & she is pulling us off them and putting us on Creon. She said she's had a few patients malabsorbing, but did not inform me if they had this same lot number... needless to say, she is not happy.

This is only on a SPECIFIC lot number H050429A expiration 6/2007 . I called my pharmacy and asked to have my bottles replaced and we keep getting the same lot number as replacements-- sometimes one or two bottles are of a different lot number and those are fine. Axcan told me there are over 6000 bottles in this particular lot. We're on the east coast and I'm assuming that these are stored in a warehouse nearby.

I have seen approx. 14 bottles with this lot number, and they are ALL the same. I did not give them to my son and do not know if they are truly defective or not- but I want to share this with you all, just in case. If you or your child is malabsorbing and you have this same lot number, please contact your CF physician.

mommyluvsjesus · 12-14-2005, 05:58 PM

Hi there, just wanted to make it known that I had the same problem but talked to Axcan and was assured they were fine. My dd has been using them even though they definetely look weird and has been doing great.

bakerswrap · 02-25-2006, 08:15 AM

My 3yr old son received the same lot number and also had issues with the medication. The first thing noticed about the pills was the color & the shape of the beads. Then my son started having very frequent rancid BM's. My son has been on the Ultrase since he was diagnosed CF at six months.
The pills had always been white in color and the beads uniform in shape. I called in a new prescription order to my pharmacy and they could not get any Ultrase in, then I contacted my son CF clinic any they could not get any in. My son's CF doctor has now placed him in Pancrease.
I've contacted Axcan and have spoken to 5 different persons regarding this issue. They have assured myself that the pills have passed Q/A. I am not believing it!! There has been mulitple complaints on the Lot # and it is suspicous that right after this lot number came out, the pills were not available for a little while.
Axcan is refunding my copays for this product, but they will not give out any figures on how this lot number passed quality assurance.

sherry092 · 02-25-2006, 11:17 PM

Funny, I couldn't get an answer from Axcan either...... I spoke with them several times, and they asked me to send some of my pills in so they could be checked, and again, I never heard a word. I called them back and they said there was nothing wrong with the pills- but I'm not buying it.