Thymoglobulin
DATE RECALL INITIATED:
April 9, 2008
PRODUCT / LOT NUMBER / EXPIRATION DATE:
Anti-thymocyte Globulin (Rabbit) 25 mg/vialNDC # 58468-0080-1
Lot Numbers: C7014C01 (Expires May 31, 2010)
C7008C01 (Expires March 31, 2010)
TH175-05 (Expires October 4, 2009)
MANUFACTURER:
Genzyme Corporation
Framingham, Massachusetts
REASON:
Genzyme Corporation , Genzyme Europe B.V., and Genzyme Polyclonals, S.A.S. are initiating a voluntary recall of Thymoglobulin finished product lots: C7014C01, C7008C01, and TH175-05. This recall was initiated when Thymoglobulin lot C7014C01 failed a periodic stability test based upon appearance of the reconstituted product. Reconstituted solution from lot C7014C01 initially passed this stability test prior to market release. The specification for the appearance of reconstituted Thymoglobulin solution is a clear, limpid to slightly opalescent liquid. Samples from lot C7014C01 have recently exceeded the slightly opalescent stability specification based upon visual examination of the reconstituted product. The 2 additional lots involved in this recall, lot numbers TH175-05 and C7008C01, are being recalled based on a predicted stability failure for appearance prior to the labeled expiration dates. Customers are asked to immediately discontinue all use of these lots and to return all Thymoglobulin vials to Genzyme Corporation.
tag: FDA Recall, Medical Recalls, Thymoglobulin Recall, Genzyme Corporation Recall, Anti-thymocyte Globulin,
4 comments:
Hi..Can you give me the F.D.A link where this info can be found.
Thank you.
So you can charge people for information ;).
It will be out in the normal recall link on Monday I think!
You can use this data, it is as good as it gets!
Whoa, such hostility.
I dont need your data, as i listed this item when it was recalled Apr.9/08.
I wanted to make sure you did not copy it off my site...You would do the same, if you ran a business...
But a blog is not a business, and you can see there are major differences in our services.
And as such, I do not know of any businesses who do work for FREE...
If you want to work for FREE, then come work for me. I dont mind.
Enough sillyness, if you would like to discuss any issues about our services, you can contact me at any time on my site.
Take care.
Hello RecallKing,
Had you asked the question directly, we could have avoided unpleasantness.
Anyway the comment was a joke, did you see the smiling face.
Anyway I did not copy from you. Good if you got the data faster than me. Hey I have nothing against you making money. If people are willing to pay, why not.
Peace!
Post a Comment