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Elli · 03-27-2005, 04:52 PM

"4. What were the manufacturing problems that resulted in FDA's seizure action?

FDA inspections revealed that some lots of Avandamet tablets are not always manufactured uniformly and that these tablets may not have an accurate dose of rosiglitazone (one of the two active ingredients in Avandamet). FDA also found that some lots of Paxil CR tablets are not manufactured properly and can split apart, so that patients may receive a portion of the tablets that lack any active ingredient or a portion that contains the active ingredient and does not have the intended controlled-release effect."

http://www.medadnews.com/News/index....ticleid=218175

03-27-2005, 04:52 PM
Elli Reach for those stars! Industry Role: Join Date: Apr 2003 Location: Vancouver, BC Posts: 17,991	"4. What were the manufacturing problems that resulted in FDA's seizure action? FDA inspections revealed that some lots of Avandamet tablets are not always manufactured uniformly and that these tablets may not have an accurate dose of rosiglitazone (one of the two active ingredients in Avandamet). FDA also found that some lots of Paxil CR tablets are not manufactured properly and can split apart, so that patients may receive a portion of the tablets that lack any active ingredient or a portion that contains the active ingredient and does not have the intended controlled-release effect." http://www.medadnews.com/News/index....ticleid=218175 __________________ email: [email protected]