ChemLifeIntel/Companies/Radnostix, Inc.

Radnostix, Inc.

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INTELLIGENCE

Showing 2 of 2 briefs on Radnostix, Inc.

REGULATORY INTELLIGENCE·Recall

Radnostix Recalls SODIUM IODIDE I-131 Capsule Kits Due to Failed Specifications, Impacting US Supply

Radnostix, Inc. has initiated a Class III voluntary recall (D-0401-2026) for 2,699 blister cartons of its Gelatin Capsule Pack, intended for use with the SODIUM IODIDE I-131 Kit, due to failed tablet/capsule specifications. This nationwide recall from their Idaho Falls, ID facility underscores critical quality control challenges for ancillary drug components, impacting supply chain reliability.

90-Day Activity

Radnostix,Sodium Iodide I 131

PSPriya Subramaniam· Intelligence Analyst

2026-04-01

REGULATORY INTELLIGENCE·Warning Letter

Radnostix Initiates Class II Recall of Sodium Iodide I-131 Due to Particulate Matter, Heightening Radiopharmaceutical Supply Scrutiny

Radnostix, Inc. has initiated a Class II recall for 16 units of Sodium Iodide I-131 Solution, Therapeutic Oral, manufactured by International Isotopes Inc. in Idaho Falls, ID. This voluntary action, prompted by particulate matter from production issues, necessitates immediate review of radiopharmaceutical supply chains. Procurement and regulatory teams must assess quality control and supply continuity risks for this critical therapeutic agent.

90-Day Activity

Radnostix,Sodium Iodide I 131

PSPriya Subramaniam· Intelligence Analyst

2026-03-11 Warning Letter