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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.: Diflorasone Diacetate Ointment Recalled for Foreign Substance Presence

Agency Publication Date: June 23, 2021
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Summary

Teligent Pharma, Inc. is recalling 6,240 tubes of Diflorasone Diacetate Ointment USP, 0.05% (generic prescription cream) because foreign particles were found in the product during routine stability testing. The recall affects both 15 g and 30 g tubes distributed across the United States. If you have this medication, you should consult with a healthcare professional before making any changes to your treatment.

Risk

The presence of unknown foreign particles in a topical ointment can cause skin irritation, inflammation, or infection when applied to the body. While no injuries have been reported, the contamination was discovered during quality testing and the product no longer meets safety standards.

What You Should Do

  1. Check your medicine cabinet for Diflorasone Diacetate Ointment USP, 0.05% in 15 g tubes (NDC 52565-063-15) or 30 g tubes (NDC 52565-063-30).
  2. Verify the lot number and expiration date on the bottom of the tube or the carton flap: this recall specifically affects Lot 16264 with an expiration date of November 2022.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if you should stop using the affected ointment.
  4. Return any unused tubes from Lot 16264 to the pharmacy where you purchased them for a refund.
  5. Contact the manufacturer, Teligent Pharma, Inc., at their New Jersey facility for further instructions regarding the return process.
  6. For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

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

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

Affected Products

Product: Diflorasone Diacetate Ointment USP, 0.05% (15 g)
Model:
NDC 52565-063-15
Lot Numbers:
16264 (Exp Nov 2022)
Date Ranges: Expiration Date November 2022
Product: Diflorasone Diacetate Ointment USP, 0.05% (30 g)
Model:
NDC 52565-063-30
Lot Numbers:
16264 (Exp Nov 2022)
Date Ranges: Expiration Date November 2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87950
Status: Resolved
Manufacturer: Teligent Pharma, Inc.
Sold By: pharmacies
Manufactured In: United States
Units Affected: 6,240 tubes
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.