CLASS II Drug recall · Reported 1 Apr 2020 · FDA Enforcement Report
Draximage Dtpa (Kit For The Preparation OF Technetium TC recalled
Jubilant Draximage is recalling Draximage Dtpa (Kit For The Preparation OF Technetium TC 99M Pentetate Injection), 20 mg, distributed nationwide in the US. The recall was initiated on 19 Mar 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1062-2020
- FDA event ID
- 85226
- Recalling firm
- Jubilant Draximage, Kirkland, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Mar 2020
- FDA classified
- 25 Mar 2020
- Reported
- 1 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 19 Mar 2020 | Recall initiated by company | |
| 25 Mar 2020 | Classified by FDA | +6 days |
| 1 Apr 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Product was distributed throughout the United States.
Stores named: Costco
Questions about this recall
Why was it recalled?
Failed Stability Specifications
Which lots are affected?
Lot # 8K143, Exp 10/31/2020.
Where was it sold?
Product was distributed throughout the United States.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Jubilant Draximage
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Draximage MAA (Kit for the preparation of Technnetium Tc recalledDraximage Maa | Jubilant Draximage | Sterility | Nationwide |
| Drug | CLASS III | Sodium Iodide I, USP Diagnostic Oral recalled by Jubilant DraximageSodium Iodide I 131 Diagnostic | Jubilant Draximage | Other | Nationwide |