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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Pharmalucence, Inc.: Preparation Kits for Technetium TC-99M Mebrofenin Recalled for Stability Failure

Agency Publication Date: May 15, 2018
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Summary

Pharmalucence, Inc. is recalling 621 units of the Kit for the Preparation of Technetium TC-99M Mebrofenin, a radiopharmaceutical drug used in diagnostic imaging. The recall was initiated because the product failed stability specifications, meaning the drug may not maintain its intended potency or quality through its labeled shelf life. Consumers should be aware that this affects both 5-count and 30-count packages distributed nationwide. If you have been treated with this medication, you should consult your healthcare provider to determine if any follow-up is necessary.

Risk

The drug failed stability testing, which can result in the medication not working as intended during diagnostic procedures, potentially leading to inaccurate medical imaging results or the need for repeat scans.

What You Should Do

  1. Identify if you have the affected product by checking the packaging for Part Number MEM05 (5-count) or MEB30 (30-count) with an expiration date of 12/2018.
  2. Verify the NDC numbers on the label: NDC 45567-0455-1 for the 5-count kit and NDC 45567-0455-2 for the 30-count kit.
  3. Immediately stop using the affected kits and secure any remaining inventory.
  4. Contact your healthcare provider or pharmacist for guidance regarding any medical concerns or to discuss previous treatments using these kits.
  5. Return any unused product to the place of purchase or pharmacy for a refund and contact Pharmalucence, Inc. for further instructions on returning the goods.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product for refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Kit for the Preparation of Technetium TC-99M Mebrofenin (5 count)
Model:
MEM05
NDC 45567-0455-1
Recall #: D-0815-2018
Lot Numbers:
Part Number MEM05 (Exp 12/2018)
Date Ranges: 12/2018
Product: Kit for the Preparation of Technetium TC-99M Mebrofenin (30 count)
Model:
MEB30
NDC 45567-0455-2
Recall #: D-0815-2018
Lot Numbers:
Part Number MEB30 (Exp 12/2018)
Date Ranges: 12/2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79802
Status: Resolved
Manufacturer: Pharmalucence, Inc.
Sold By: Hospitals; Radiopharmacies; Diagnostic Imaging Centers
Manufactured In: United States
Units Affected: 157 units (5 count) and 464 units (30 count)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.