Radnostix recalled 2,699 gelatin capsule packs used with its Sodium Iodide I-131 kit, distributed nationwide in the United States and Puerto Rico. The capsules failed to meet tablet/capsule specifications. Healthcare providers and patients should stop using the product and contact Radnostix for guidance.
Failed Tablet/Capsule Specifications
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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Gelatin capsule packs are components used with radiopharmaceutical kits, specifically the Sodium Iodide I-131 kit. They include capsules intended for medical procedures.
The failed tablet/capsule specifications may affect dosage accuracy or capsule integrity, potentially impacting treatment effectiveness or safety.
This recall is not identified as part of a broader industry pattern in the provided information.
No reported injuries to date. The recall requires immediate cessation of use to mitigate potential risks.
Recall notices and lot/NDC details are on the FDA enforcement page linked in the recall notice. Manufacturer letters will provide next steps.
Refunds or replacements are typically processed within 4-8 weeks after the recall resolution is confirmed by the company.
Retain recall letter, purchase receipts, lot/NDC numbers, and any correspondence with Radnostix or healthcare providers.
Product: Gelatin Capsule Pack for Sodium I-131 Kit. Contains 5 empty capsules and 5 Dibasic Sodium Phosphate capsules (300 mg). NDCs: 69208-003-15; 69208-003-25; 69208-003-35. Quantity: 2,699 blister cartons. Distributed nationwide in the US, including Puerto Rico. Sold by: Radnostix, Inc. Model numbers: Lot 3666245; Lot 4546213; Lot 4951280. Expirations: 02/28/2026 for first two lots, 09/30/2027 for Lot 4951280.
No injuries or incidents have been reported.
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