December 8, 2010
As of December 10, 2010, the former FDA 24-hour emergency number, 301-443-1240, will be disconnected. The new numbers for the Office of Emergency Operations will be 1-866-300-4374 or 301-796-8240.
These numbers can be used to report the following types of problems to FDA:
A serious, life-threatening event involving an FDA-regulated product, i.e., foods, dietary supplements, cosmetics, human drugs, animal drugs, medical devices, biological products, and radiation-emitting electronic products
Requests from medical professionals for approval for the use of an emergency investigational new drug, device or biologic.
Notifications to FDA from government agents acting in an official capacity about an urgent matter.
Reports of an emergency involving an FDA employee or an FDA employee's family member.
Reports of a non-life threatening adverse reaction to an FDA-regulated product that requires immediate reporting.