United StatesEmdogain demonstration-only product (Article No. 440.230V10; lots EPZM8, HPT6, KEWN9, NAAM6, VAW80; and Article No. 475.132V10; lots CRL56, HPHJ1), 61 units, distributed in AZ, CA, DE, FL, ID, MO, TN, TX, UT and VA. It was recalled because the demonstration-only product could potentially be placed in patients.
What's being recalled
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Recalling firm: Straumann USA LLC, Andover, MA, United States.
How to identify it
1. Article Number: 440.230V10; UDI-DI: N/A; Lot Numbers: EPZM8, HPT6, KEWN9, NAAM6, VAW80; 2. Article Number: 475.132V10; UDI-DI: N/A; Lot Numbers: CRL56, HPHJ1;
The hazard
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)