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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

Edge Pharma, LLC: Vancomycin HCL IV Bags Recalled for Incorrect Label Strength

Agency Publication Date: September 7, 2020
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Summary

Edge Pharma, LLC is voluntarily recalling 5 IV bags of Vancomycin HCL 1.5 mg because of a labeling error regarding the declared strength of the medication. This prescription antibiotic (generic Vancomycin) was distributed in Wisconsin and could lead to dosing errors if administered. Consumers who may have been treated with this specific medication should contact their healthcare provider or pharmacist immediately, as only a small number of units are affected.

Risk

The product label incorrectly states the strength of the medication, which can lead to a patient receiving either too much or too little of the drug, potentially causing severe adverse health consequences or ineffective treatment.

What You Should Do

  1. Identify if you have the affected product by checking the label for 'Vancomycin HCL 1.5 mg' with NDC 05446-1458-01.
  2. Specifically look for Lot # 06-2020-04@2 with a Beyond Use Date (BUD) of 09-16-2020 or Lot # 06-2020-04.
  3. Contact your healthcare provider or pharmacist immediately for guidance if you believe you have received this medication.
  4. Return any unused product to the place of purchase or pharmacy for a refund and contact Edge Pharma, LLC at 856 Hercules Dr, Colchester, VT 05446 for further instructions.
  5. For additional questions or to report a problem, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full 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: Vancomycin HCL 1.5 mg (IV bag)
Model:
NDC 05446-1458-01
Recall #: D-1562-2020
Lot Numbers:
06-2020-04@2
06-2020-04
Date Ranges: BUD 09-16-2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86324
Status: Resolved
Manufacturer: Edge Pharma, LLC
Sold By: Hospitals; Clinics
Manufactured In: United States
Units Affected: 5 IV bags
Distributed To: Wisconsin

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 · 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.