2023 Meeting Materials, Cardiovascular and Renal Drugs Advisory Committee

FOR IMMEDIATE RELEASE – October 31, 2025 AUSTIN, TX – Otsuka ICU Medical LLC is issuing a voluntary recall to the user level, for a MISLABELLED lot of POTASSIUM CHLORIDE Inj. 20 mEq, NDC 0990-7077-14. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product

The Food and Drug Administration is advising consumers not to purchase or use MEGA 7G 700000, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

CGMP/Finished Pharmaceuticals/Adulterated

C3TI aims to promote the adoption of pragmatic design in clinical trials and improve coordination and collaboration between CDER and sponsors to effectively support these innovative trials.

Part of Safe Use Initiative
(updated)

CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative