Drug product
Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml V-Vial, NDC 69208-003-25; Order 49353,49457, 49477. (c) 3 ml V-vial, NDC 69208-003-35; Order 49454,49406. Rx Only, Manufactured by: International Isotopes Inc., Idaho Falls, ID.
D-0389-2026
Product summary
- Firm
- Radnostix
- Event
- Event 98470
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16 units
- Official record key
drug-enforcement:D-0389-2026
Official wording
Reason: Presence of Particulate Matter: Due to production issues
Code information: Batch I012626R-01, Exp 02/09/2026
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter