FDA-Drug2026-04-01Class III
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35
Radnostix
Hazard
Failed Tablet/Capsule Specifications
Sold states
Nationwide in the US, including Puerto Rico
Affected count
2,699 blister cartons
Manufactured in
4137 Commerce Cir, Idaho Falls, ID, United States
Products
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0401-2026Original summary
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35 Failed Tablet/Capsule Specifications Lot, expiry: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027 Distribution: Nationwide in the US, including Puerto Rico Affected quantity: 2,699 blister cartons
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