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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- 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
Presence of particulate matter due to production issues. The contamination could affect the safety and efficacy of the radiopharmaceutical when administered.
1. Stop using the product. 2. Contact Radnostix or your healthcare provider for guidance. 3. Await recall notification by letter. 4. If you possess the product, consult your pharmacist or physician about next steps. 5. Follow all instructions provided by Radnostix or your healthcare provider.
Recall administration is described on the FDA enforcement page linked below. Direct consumer contact information is not provided in the release. For guidance, consult your healthcare provider or the FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0389-2026
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