FDA DrugsClass III
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empt...
Published: April 1, 2026Recall ID: D-0401-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Tablet/Capsule Specifications
Product Description & Identification
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
Affected 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
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 | 98492 |
| Address 1 | 4137 Commerce Cir |
| Code info | Lot, expiry: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027 |
| Postal code | 83401-1205 |
| Report date | 20260401 |
| Product type | Drugs |
| Product quantity | 2,699 blister cartons |
| Reason for recall | Failed Tablet/Capsule Specifications |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260219 |
| Initial firm notification | Letter |
| Center classification date | 20260320 |
Overview
- Recalling FirmRadnostix
- StatusOngoing
- Risk LevelClass III
- DistributionNationwide in the US, including Puerto Rico