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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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Low RiskFDA Drug
Medications & Supplements/Topical Products

Teligent Pharma, Inc.: Triamcinolone Acetonide Lotion Recalled for Being Subpotent

Agency Publication Date: November 25, 2020
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Summary

Approximately 4,008 units of Triamcinolone Acetonide Lotion USP, 0.025% (60 mL bottles) are being recalled because the drug was found to be subpotent. This prescription topical medication may not contain the necessary strength of its active ingredient, meaning it might not effectively treat the skin conditions for which it was prescribed. The affected product can be identified by Lot Number 14481 and was distributed to pharmacies nationwide. Consumers should consult with their healthcare provider to discuss alternative treatments.

Risk

The drug is subpotent and failed to meet assay results, which means it is less effective than required. This may result in inadequate treatment of inflammatory or itchy skin conditions, though no injuries or adverse effects have been reported to date.

What You Should Do

  1. Check your prescription medication to see if you have Triamcinolone Acetonide Lotion USP, 0.025% in a 60 mL (60 gram) bottle.
  2. Verify if your bottle is part of the recall by looking for Lot Number 14481 with an expiration date of 10/31/2021 and National Drug Code (NDC) 52565-010-59.
  3. If your product matches these identifiers, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription.
  4. Return any unused portion of the recalled lotion to your pharmacy to receive a refund.
  5. For further instructions regarding the recall, contact the manufacturer, Teligent Pharma, Inc., at their Buena, New Jersey location.
  6. Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional assistance.

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: Consumers should return the recalled medication to their place of purchase for a refund and seek medical guidance from a professional.

Affected Products

Product: Triamcinolone Acetonide Lotion USP, 0.025% (60 mL/60 grams)
Model:
NDC 52565-010-59
Recall #: D-0110-2021
Lot Numbers:
14481 (Exp 10/31/2021)
Date Ranges: Expiration 10/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86705
Status: Resolved
Manufacturer: Teligent Pharma, Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 4008 units
Distributed To: Nationwide

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.