Advanced Accelerator Applications USA, Inc. has recalled 14,089 units of its NETSPOT (Ga 68 dotatate injection) preparation kits. The recall was initiated because stability studies showed that Vial 1 of the kit was "subpotent," meaning it contained lower levels of the active ingredient than required. No incidents or injuries have been reported to date in connection with this issue. The product is used primarily in hospitals, imaging centers, and specialty pharmacies for diagnostic procedures.
A subpotent drug may not contain enough of the active ingredients to perform as intended. In this case, it could lead to inaccurate or unclear results during diagnostic medical imaging scans.
Rx Only. Kit contains Vial 1 (Reaction vial with lyophilized powder) and Vial 2 (Reaction buffer).
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.