Radnostix, Inc. is recalling 16 units of SODIUM IODIDE I-131 Solution distributed nationwide in the United States and Puerto Rico. The product contains particulate matter due to production issues. Healthcare providers and patients should stop using the product immediately and await a recall notification by letter.
Presence of Particulate Matter: Due to production issues
Consumers and healthcare providers should stop using this product immediately. Contact Radnostix or your healthcare provider for guidance. Notification method: Letter
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Sodium Iodide I-131 Solution is a radiopharmaceutical used in therapy for certain thyroid conditions. The product is supplied in 1 ml, 2 ml, and 3 ml V-Vials with corresponding NDCs.
Particulate matter in the solution can compromise safety and efficacy. Contamination could affect dosage accuracy and patient safety.
This recall is not reported as part of a broader industry pattern.
Health care providers may need to pause treatments and seek alternative therapies. Patients could face delays in therapy while replacements are sourced.
Label on vial or packaging shows NDC, batch, and expiration date
Recall notices typically include next steps; refunds or replacements may take weeks (4-8 weeks commonly)
Keep recall notice, prescriptions, batch numbers, receipts, and all correspondence
- Model numbers: Batch I012626R-01; Exp 02/09/2026 - NDC codes: 69208-003-15 (1 ml), 69208-003-25 (2 ml), 69208-003-35 (3 ml) - Sold as Rx Only - Manufactured by: International Isotopes Inc., Idaho Falls, ID - Quantity recalled: 16 units - Distribution: Nationwide in the USA and Puerto Rico - Price: Not disclosed
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