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Posted by: Les from Canada ® 01/25/2006, 22:06:06 |
Hi Everybody; I haven't been posting of late but I've checked the board fairly regularly. Recently I came across word of a recall on Genteal Gel that may possibly affect some of you. I don't see anything posted, so I'm posting the link for the Novartis site below. Here's the toll-free number for Novartis from the site: 1-866-393-6336 Even if you don't have one of the recalled lots, I wouldn't hesitate to call if you have questions. Related link: Genteal Recall Modified by Les from Canada at Wed, Jan 25, 2006, 22:07:19 |
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Posted by: Les from Canada ® 01/25/2006, 22:24:57 |
Hi again; The link doesn't seem to be working for me, so here is the site address: http://www.us.novartisopthalmics.com/info/tools/genteal.jsp I hope nobody has had problems with the product. Les |
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Posted by: judith k ® 01/26/2006, 01:28:53 |
Novartis Ophthalmics Recalls Seven Lots of GenTeal® Products in the US Contact:
FOR IMMEDIATE RELEASE - East Hanover, NJ -- November 16, 2005 -- Novartis Ophthalmics announced today it has voluntarily recalled a total of seven lots of two products intended for use in the eye. Novartis Ophthalmics takes its mission of patient care and providing quality products very seriously, and therefore, believes it is necessary to take this precautionary action. The recalls are being conducted with the knowledge of the FDA. Novartis Ophthalmics is recalling five lots of GenTeal® Gel, a non-prescription drug product used to relieve dryness of the eye. The five lots of GenTeal® Gel being recalled are: Lot #Z12468, 10 ml, expiration date 01/2006; Lot #Z12912, 3.5 ml, expiration date 03/2006; Lot #Z12900, 10 ml, expiration date 04/2006; Lot #Z13161, 10 ml, expiration date 05/2006; and Lot #Z13314, 3.5 ml, expiration date 06/2006. The five lots include about 142,500 tubes that were distributed nationwide from March to November 2004. The GenTeal® Gel recall is being conducted following concerns regarding sterility of the product made for Novartis by a contract manufacturer. Additional sterility tests were conducted on several lots of GenTeal® Gel. Test results indicated the presence of mold in a small number of samples, leading Novartis to initiate a recall of the five lots. The species of mold that is suspected is generally not harmful, but has the potential to cause an eye infection in susceptible people, especially in those with compromised immune systems. Novartis Ophthalmics is also recalling two lots of GenTeal® GelDrops. The two lots are Lot #51139, 15 ml, expiration date 07/2007; and Lot #51283, 25 ml, expiration date 07/2007. The two lots include about 12,000 dropper bottles that were distributed nationwide in October 2005. The GenTeal® GelDrops lots are being recalled due to a lack of sterility assurance. While the risk of potential contamination is believed to be very low, contaminated product could cause infections in susceptible people, and Novartis initiated the recall as a precautionary measure. The sterility assurance issues have been corrected. Only the two distributed GenTeal® GelDrops lots are affected. Consumers who have purchased GenTeal® Gel or GenTeal® GelDrops with any of these lot numbers should contact Novartis Ophthalmics at 1-866-393-6336.
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Posted by: Steve-In-Tennessee ® 01/26/2006, 15:04:06 |
Judith K, Thanks for all the info, I have printed it out to take home tonight and get with Jennifer and see if we have any of the recalled items. I hope that you are doing well & had a wonderful holiday season. Well I guess I better get back to work. Thanks again for the info, that was very nice of you to go through the trouble & post it. Steve |
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Posted by: judith k ® 01/27/2006, 00:03:38 |
Hi Steve,
Nice to see your post. Bet you DON'T have any of the recalled items. I am doing ok, it's been 3 1/2 months since my last shots and the Botox is still pretty effective, eyes just getting a little 'pully', but no spasms. I hope you are doing well. Hi to Jennifer and Happy New Year to you both. Judith K |
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Posted by: Kathleen ® 01/26/2006, 08:08:43 |
Not Again! I was so happy to see that they finally have it back on the shelves around here after the last recall and manufacturing glitch. Now I suppose it'll be another year before the supply can meet the needs. Oh well, better that than having mold growing in your eyes, euww, GROSS. : ) |
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Posted by: judith k ® 01/26/2006, 13:58:46 |
I remember reading about this recall a while ago. There are only a very few production places affected.
It's NOT a recall of ALL Genteal Gel. I was stocking up (from Canadian pharmacies, and one in the US) when it wasn't on the shelves, and I have a bunch of tubes from all these sources; I've checked the lot numbers, and none of them are in the recalled batches. I've been using it every night and it seems fine. So if you like Genteal, chances are your store will have the UNRECALLED ones. Judith K (in my previous post, I have the batches that have been recalled; the batch numbers are printed on each box) Modified by judith k at Thu, Jan 26, 2006, 14:00:06 |
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Posted by: Moderator-JB ® 01/26/2006, 11:54:37 |
Les & everyone, The net of education that we've expanded across the world, is one of knowledge. How many of you would have known of this recall, if Les had not posted the information. Great going!!! Have a good eye day, Judy |
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Posted by: June in Toronto ® 01/26/2006, 15:17:27 |
Thanks Les and Judith for the GenTeal information. I wouldn't have known BUT my pharmacist did and, apparently, didn't sell any of the products to be recalled. I took Judith's post into him and he was well aware of it. You are right, Judy, the things we learn on this bb is amazing. June in Toronto |
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Posted by: Les from Canada ® 01/26/2006, 16:59:45 |
Hi Everybody, Thanks Judith for posting all the information. I did realize that it was only specific lots and I should have mentioned that. I'm glad for those who use it that there seems to be plenty of safe product available. I just wanted everyone to be aware and to check it out. Les |
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