Radnostix Gelatin Capsule Pack recalled for failed capsule specifications
Radnostix Gelatin Capsule Packs used with Sodium Iodide I-131 Kit have failed quality specifications. The affected capsules may not perform as intended. Three specific lots distributed nationwide are involved.
From the FDA notice · Read the official notice ↗
What to do
- Check if you have Radnostix Gelatin Capsule Pack Lot 3666245, 4546213, or 4951280
- Stop using affected capsules immediately
- Contact your healthcare provider or pharmacy for instructions on next steps
Is yours affected?
Compare your label or packaging with the recalled product.
- 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
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 2,699 blister cartons
- Illnesses reported
- None reported
- Manufactured in
- 4137 Commerce Cir, Idaho Falls, ID, United States
- Classification
- Class III
- Recall number
- D-0401-2026
In the FDA's words
- Description
- 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 Failed Tablet/Capsule Specifications Lot, expiry: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027 Distribution: Nationwide in the US, including Puerto Rico Affected quantity: 2,699 blister cartons
- Hazard
- Failed Tablet/Capsule Specifications