Sodium Iodide I-131: Class III Recall Update

This MedWatch report notes a Class III recall of Sodium Iodide I-131, specifically a gelatin capsule pack intended for use with the Sodium Iodide I-131 Kit. The recall is tied to failed tablet/capsule specifications.

The product comprises five empty gelatin capsules and five Dibasic Sodium Phosphate capsules (300 mg) and is distributed by International Isotopes Inc. through Radnostix, with NDCs 69208-003-15, 69208-003-25, and 69208-003-35.

The documentation does not provide details on the exact nature of the specification failure (e.g., content, potency, uniformity, or physical characteristics) or the scope of affected lots, preventing assessment of potential clinical impact beyond the stated failure of specifications. Clinicians should be aware that the recall involves a component of a radiopharmaceutical kit and not the active radiopharmaceutical itself, based on the provided information.

Because no outcome data or corrective actions are described, there is uncertainty regarding patient exposure or safety consequences. If using or handling this kit, verify current recall status with the FDA MedWatch update and follow the manufacturer’s instructions for retrieval, quarantine, or replacement as applicable.