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FDA notice relating to New England Compounding Center product recall

Published on: Wednesday, October 17, 2012

In a statement distributed October 15 and revised October 16, the U.S. Food and Drug Administration (FDA) advised providers not to use any products distributed by the New England Compounding Center (NECC). The statement reports that on October 6, NECC announced the recall of all its products, which include solutions used in organ recovery and transplantation as well as injections, some of which have been used to treat patients later considered for organ donation.

The OPTN/UNOS Disease Transmission Advisory Committee recommends that OPO staff should consider the possibility of recent potential exposure to NECC products in potential organ donors. The risk to recipients of organs from donors who have received affected products is unknown. The transplant team will need to consider the balance of risk and benefit for each potential recipient when making the decision to accept or decline an organ from these donors.

The FDA continues to investigate the situation.