D-0389-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- March 11, 2026
- Initiation Date
- January 26, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 units
Product Description
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.
Reason for Recall
Presence of Particulate Matter: Due to production issues
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Batch I012626R-01, Exp 02/09/2026