FDA Recalls Radiopharmaceutical Kit Due to Failed Stability Specifications
Jubilant Draximage is recalling 5,209 kits of Technetium Tc 99m Sulfur Colloid Injection that failed stability specifications. The affected lots (C2300070, C2300070E) were distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II pharmaceutical recall with no reported illnesses or injuries. Per the rubric, a risk-of-harm product where injury has not yet been reported qualifies as High (3).
Plain-English summary
Jubilant Draximage Inc., dba Jubilant Radiopharma, is recalling 5,209 kits of Technetium Tc 99m Sulfur Colloid Injection, supplied as 10 mL Multi-Dose Reaction Vials in 5-vial boxes. The affected lots are C2300070 and C2300070E, with an expiration date of May 31, 2025.
The recall is due to failed stability specifications. Stability specifications ensure that the product maintains its required chemical and physical properties throughout its intended shelf life.
The affected kits were distributed nationwide in the United States.
The recalled product
- Product
- Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland , Quebec, H9H, 4J$, Canada, NDC# 65174-179-05.
- Category
- Drug — Radiopharmaceutical
- Hazard
- Affected units
- 5,209
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 (3)
- LOT C2300070 and C2300070E
- Exp. May 31
- 2025
Distribution
Distributed nationwide across the United States.
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