Showing posts with label Unapproved Drug Products. Show all posts
Showing posts with label Unapproved Drug Products. Show all posts

Sunday, May 8, 2011

A Couple of the Bigger Stories out of the FDA this Week

Here's a couple of the bigger stories out of the FDA this week.... and my personal commentary on one...

Class I Recall of Coumadin 5mg Tablets

Bristol-Meyers Squibb is recalling a single lot of brand name Coumadin (warfarin sodium) 5mg tablets because a tablet was found to be a higher potency than expected. Warfarin is a high alert drug, even small amounts can cause significant inhibition of clotting.