Jubilant DraxImage Recalls Sodium Iodide I 131 Diagnostic Due to Labeling Error
Jubilant DraxImage is recalling Sodium Iodide I 131 Diagnostic capsules due to a label error regarding the declared strength.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The specific hazard is a labeling error, which falls under the 'Low' severity criteria for documentation or packaging issues.
Plain-English summary
Jubilant DraxImage Inc. is recalling Sodium Iodide I 131 Diagnostic capsules, NDC 65174-461-05, due to a labeling error on the declared strength. The affected product consists of 90 vials (450 capsules) with Lot Number 1670123 and an expiration date of 04/16. The product was distributed nationwide.
The recall was initiated because the label contained an error regarding the declared strength of the medication. This is a Class III recall, which indicates that the product is not likely to cause adverse health consequences or death.
Consumers and healthcare providers should check their inventory for this specific lot number and NDC. If found, the product should be returned to the distributor or the manufacturer for credit. Patients who have already taken the medication should contact their healthcare provider if they have concerns.
The recalled product
- Product
- SODIUM IODIDE I 131 DIAGNOSTIC (SODIUM IODIDE I 131)
- Brand
- SODIUM IODIDE I 131 DIAGNOSTIC
- Manufacturer
- Jubilant Draximage Inc
- Category
- Drug — Radiopharmaceutical
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number 1670123
- Exp 04/16
Distribution
Distributed nationwide across the United States.
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