Messages in thread: Medical issues - re-call
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| Thread: re-call |
Posted by: J5 |
At: 14:50, 28/7/2011 |
We have checked with Baxter about the product mentioned below and apparently it has only ever been available in the United States. however, I would urge all U.S. visitors and those who may have U.S. product following travel to check all batch numbers carefully.
Sue |
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| Thread: re-call |
Posted by: Viral boy |
At: 11:36, 28/7/2011 |
Urgent Biological Re-call
Initiated by : Baxter Healthcare
Event Id : 146
Event Date : 07-27-2011
Therapy Recombinate rAHF
NDC Number Lot Number Size Packaging Expiration Date
0944283310 TRA09834AB 10 mL - 01-28-2012
Reason Baxter is voluntarily recalling one (1) lot of RECOMBINATE [Antihemophilic Factor (Recombinant)], product code 1501594, NDC Number 0944-2833-10, lot number TRA09834AB, with an expiry date of January 28, 2012.
This action is being taken as a precautionary measure after a retrospective review of manufacturing processes revealed a potential breach in aseptic processing may have occurred during the manufacture of this lot. It is important to note that this lot met all in-process and final container specifications, including sterility and pyrogenicity. There have been no reports of adverse events associated with this lot; however, in an abundance of caution, Baxter has decided to recall this particular lot of RECOMBINATE. The Food and Drug Administration has been notified of this action.
Action 1) Please check all product labels against affected lot number.
2) Do not take this product. Return affected recalled lots to the point of purchase to receive replacement product.
3) Contact your physician if you have medical questions.
Other Information If you need assistance, please call the Stericycle, Inc. at 1-888-UPDATE-U. |
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