Drug product
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
D-0401-2026
Product summary
- Firm
- Radnostix
- Event
- Event 98492
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 2,699 blister cartons
- Official record key
drug-enforcement:D-0401-2026
Official wording
Reason: Failed Tablet/Capsule Specifications
Code information: Lot, expiry: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027
Distribution pattern: Nationwide in the US, including Puerto Rico
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications