23
Oct
2012
Technical Note – PERFADEX® with THAM Solution
For our customers in North America we would like to clarify that our product PERFADEX® with THAM Solution is NOT being recalled.
Our THAM product comes from a European source and is not supplied in the form or pack sizes as listed below in the recall statement of the New England Compounding Center.
On the FDA website( http://www.fda.gov/Safety/Recalls/ucm322979.htm) the New England Compounding Center has issued a Voluntary recall of all of its products. One of these products is listed as THAM. The THAM being recalled comes in the following amounts:
THAM 0.3M (TROMETHAMINE SOLUTION), 10ML VIAL
THAM 0.3M (TROMETHAMINE SOLUTION), 250ML BAG
THAM 0.3M (TROMETHAMINE SOLUTION), 30ML VIAL
THAM 0.3M (TROMETHAMINE SOLUTION), SOOML BAG
THAM 0.3M (TROMETHAMINE SOLUTION), SOML BAG
If you have any further questions concerning this issue please contact XVIVO Perfusion at 303-395-9171.
