Jubilant Draximage Recalls DRAXIMAGE DTPA Kits Due to Stability Failures
Jubilant Draximage is recalling DRAXIMAGE DTPA kits because they failed stability specifications. The affected product was distributed throughout the United States.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity rating.
Plain-English summary
Jubilant Draximage, Inc. is recalling DRAXIMAGE DTPA (Kit for the Preparation of Technetium Tc 99m Pentetate Injection), 20 mg vial, Rx only. The recall is being conducted because the product failed stability specifications. The affected product is identified by Lot # 8K143 with an expiration date of 10/31/2020.
The recall involves 473 kits of 30 vials. The product was distributed throughout the United States. The NDC numbers for the affected product are 65174-288-05 and 67175-288-30.
Healthcare providers and patients should stop using the affected product and contact Jubilant Draximage, Inc. for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial, Rx only, Manufactured for: Jubilant Draximage, Inc., Kirkland, Quebec, Canada, NDC 65174-288-05, 67175-288-30
- 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 # 8K143
- Exp 10/31/2020.
Distribution
Distribution scope not specified by the agency.
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