Last month FDA published an amendment to its July 10, 2012 UDI proposed rule (77 FR 40736). The amendment moves up the dates of compliance. Comments on this amendment to the proposed rule are due by December 19, 2012.
“The unique identification system will enhance the flow of information about medical devices, especially adverse events and, as a result, will advance our ability to improve patient safety.” -FDA Commissioner Margaret A. Hamburg, M.D.
Bottles from the affected lots may contain tablets that have a higher dosage of acetaminophen, and as a result, it is possible that consumers could take more than the intended acetaminophen dose.
Unintentional administration of tablets with increased acetaminophen content could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day.