Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, ND...
Reason for Recall / Hazard
Presence of Particulate Matter: Due to production issues
Product Description & Identification
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.
Affected Products
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Idaho Falls |
| State | ID |
| Openfda › Route | ORAL |
| Openfda › Spl id | 490fdcc0-a035-b6f8-e063-6394a90a28a5 |
| Openfda › Brand name | SODIUM IODIDE I-131 |
| Openfda › Spl set id | 380e8e26-0625-4233-b36e-afb9f66e8a77 |
| Openfda › Package ndc › 1 | 69208-000-00 |
| Openfda › Package ndc › 2 | 69208-003-15 |
| Openfda › Package ndc › 3 | 69208-003-25 |
| Openfda › Package ndc › 4 | 69208-003-35 |
| Openfda › Product ndc | 69208-000 |
| Openfda › Generic name | SODIUM IODIDE I-131 |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Manufacturer name | Radnostix, Inc. |
| Openfda › Application number | ANDA209166 |
| Openfda › Is original packager | true |
| Event id | 98470 |
| Address 1 | 4137 Commerce Cir |
| Address 2 | N/A |
| Code info | Batch I012626R-01, Exp 02/09/2026 |
| Postal code | 83401-1205 |
| Report date | 20260311 |
| Product type | Drugs |
| Product quantity | 16 units |
| Reason for recall | Presence of Particulate Matter: Due to production issues |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260126 |
| Initial firm notification | Letter |
| Center classification date | 20260313 |
Overview
- Recalling FirmRadnostix
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA and Puerto Rico