Use caution Drug recall · FDA · Published March 19, 2020

Draximage DTPA Recall: Failed Stability Specs

Jubilant Draximage recalls specific lots of DTPA injection kits due to failed stability specifications. Check lot numbers and expiration dates immediately.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1062-2020Drug Draximage ›

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Failed Stability Specifications

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Contact the company

Recalling firmJubilant Draximage Inc16751 Rte Transcanadienne · Kirkland, Canada

✎ GovInfoNow plain-language explainer

Jubilant Draximage Inc is recalling DRAXIMAGE DTPA, a kit used for preparing Technetium Tc 99m Pentetate Injection, because the product failed stability specifications. The recall affects 473 kits of 30 vials distributed throughout the United States. No specific remedy or action steps are currently listed in the record. Read more at govinfonow.com/recall/37292-draximage-dtpa-recall-failed-stability-specs.

Source Summary by GovInfoNow · govinfonow.com/recall/37292-draximage-dtpa-recall-failed-stability-specs · Updated October 11, 2026 · FDA enforcement record: FDA #D-1062-2020

Cite this page

“Draximage DTPA Recall: Failed Stability Specs.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/37292-draximage-dtpa-recall-failed-stability-specs. Based on FDA recall #D-1062-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1062-2020%22&limit=1).

The FDA announced on March 19, 2020, that Jubilant Draximage Inc. recalled DRAXIMAGE DTPA injection kits due to failed stability specifications. The Class II recall was voluntary and has since been terminated.

How to tell if you have it

Brand: Draximage
Product: DTPA Injection Kit (Kit for the Preparation of Technetium Tc 99m Pentetate Injection)
NDCs: 65174-288-05, 67175-288-30
Lot #: 8K143
Expiration Date: 10/31/2020
Quantity: 473 kits of 30 vials

The hazard

The recall addresses failed stability specifications for the DRAXIMAGE DTPA product. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Jubilant Draximage Inc. has two other recalls on record since March 11, 2016. Other recent recalls of similar products include Apotex Paxil CR 37.5mg Tablets Recall (August 13, 2026) and Somerset Therapeutics Cisatracurium Besylate Injection Recall (November 26, 2025).

How to tell if you have this one

Look for DRAXIMAGE DTPA kits (20 mg vial, Rx only) with NDC numbers 65174-288-05 or 67175-288-30. Specifically check for Lot # 8K143 with an expiration date of 10/31/2020.

Brand
Draximage
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify if you have DRAXIMAGE DTPA kits with NDC 65174-288-05 or 67175-288-30, Lot # 8K143, expiring 10/31/2020.
Contact Manufacturer
Since the remedy is not stated in the record, contact Jubilant Draximage Inc for further instructions on how to handle these specific lots.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Product was distributed throughout the United States.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 14 months after the firm started it.

Mar 19, 2020Firm started the recall
Mar 25, 2020FDA classified it Class II
Apr 1, 2020Published in FDA’s Enforcement Report
May 19, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/37292-draximage-dtpa-recall-failed-stability-specs">Draximage DTPA Recall: Failed Stability Specs (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1062-2020 (March 19, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1062-2020 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.