Pharmalucence Kit for Technetium TC-99M Mebrofenin Recall: Failed Stability Specifications
Pharmalucence recalls kits for Technetium TC-99M Mebrofenin due to failed stability specifications. These kits may degrade over time, posing risks to medical procedures.
Lower-risk recall
Failed Stability Specifications
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What happened, in plain English
Pharmalucence is recalling kits for Technetium TC-99M Mebrofenin that failed stability tests. This could lead to degraded product quality, potentially affecting medical procedures if used improperly. Read more at govinfonow.com/recall/40622-pharmalucence-kit-for-technetium-tc-99m-mebrofenin-recall-failed-stability.
Source Summary by GovInfoNow · govinfonow.com/recall/40622-pharmalucence-kit-for-technetium-tc-99m-mebrofenin-recall-failed-stability · Updated October 7, 2026 · FDA enforcement record: FDA #D-0815-2018
Cite this page
“Pharmalucence Kit for Technetium TC-99M Mebrofenin Recall: Failed Stability Specifications.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40622-pharmalucence-kit-for-technetium-tc-99m-mebrofenin-recall-failed-stability. Based on FDA recall #D-0815-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0815-2018%22&limit=1).
Why it’s dangerous
The kits failed stability specifications, meaning the radioactive tracer may degrade over time. This could lead to inconsistent results in medical imaging tests if used after the expiry date.
Who’s affected
Healthcare facilities and medical professionals who use these kits for nuclear medicine procedures. The risk is low as the kits are for medical use and not consumer products.
How to tell if you have this one
Check for the product name 'Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL' with NDC numbers 45567-0455-1 or 45567-0455-2. These kits were manufactured with an expiry date of 12/2018.
- Brand
Pharmalucence- Category
Drug
What to do — step by step
Check Expiry Date
Verify the expiry date on the kit; if it's past December 2018, it should not be used.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0815-2018 (April 10, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0815-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.