Infusion Pump Correction: ICU Medical, Inc. Issues Correction for Plum Duo Infusion System Due to Software Possibly Resulting in Pump Becoming Unresponsive

These letters are supplied by the CDER Freedom of Information Office and only cover Office of Prescription Drug Promotion’s untitled letters. FDA may have redacted or edited some of the letters to remove confidential information.

The U.S. Food and Drug Administration has approved drug labeling changes to six menopausal hormone therapy products, also known as hormone replacement therapy (HRT), to clarify risk considerations for these drugs.

FDA held a meeting with several states to discuss the section 804 importation program (SIP), which allows states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the cost of these drugs to the American consumer.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Town Food Service Equipment Co., Inc. of Brooklyn, NY is recalling aluminum saucepans, because it has the potential to be contaminated with lead (Pb) which may leach into food. Lead is toxic to humans and can affect people of any age or health status, and there is no known safe level of exposure to

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