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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/Topical Products

Teligent Pharma, Inc.: Flurandrenolide Ointment Recalled for Failed Impurity Specifications

Agency Publication Date: April 22, 2021
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Summary

Teligent Pharma, Inc. is recalling 3,432 tubes of Flurandrenolide Ointment USP, 0.05% (60-gram tubes) because the product failed to meet stability testing requirements for impurities and degradation. This means the medication may contain higher-than-allowed levels of breakdown products, which could affect the safety or effectiveness of the ointment. This prescription medication is used to treat various skin conditions and was distributed nationwide. If you have this medication, you should contact your healthcare provider or pharmacist for guidance and return any unused product to the pharmacy for a refund.

Risk

The product failed testing specifications for impurities and degradation, which could potentially lead to reduced effectiveness of the treatment or unexpected side effects from the degraded chemical components.

What You Should Do

  1. Check your ointment tube and outer packaging for Flurandrenolide Ointment USP, 0.05% in a 60-gram tube with NDC 52565-017-60.
  2. Verify if your product belongs to Lot #13974 with an expiration date of 7/2021.
  3. If you have the affected product, contact your healthcare provider or pharmacist for guidance on continuing your treatment.
  4. Return any unused portions of the medication from Lot #13974 to the pharmacy where you purchased it for a refund.
  5. Contact Teligent Pharma, Inc. at their Buena, New Jersey location for further instructions regarding this recall.
  6. For additional questions or to report a complaint, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmacy refund and healthcare consultation

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

Affected Products

Product: Flurandrenolide Ointment USP, 0.05% (60 grams)
Model:
NDC 52565-017-60
Lot Numbers:
13974 (Exp 7/2021)
Date Ranges: 7/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87694
Status: Active
Manufacturer: Teligent Pharma, Inc.
Sold By: pharmacies
Manufactured In: United States
Units Affected: 3432 tubes
Distributed To: Nationwide
Agency Last Updated: April 28, 2021

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.