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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.: Lidocaine Ointment Recalled for Failure to Meet Quality Viscosity Standards

Agency Publication Date: April 12, 2021
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Summary

Teligent Pharma, Inc. is recalling approximately 62,040 tubes of Lidocaine Ointment USP, 5% (generic lidocaine). This prescription topical medication was found to fail stability specifications because it did not meet required viscosity (thickness) results during testing. Because the ointment may not have the correct consistency, it may not perform as expected or could lead to inconsistent dosing. Consumers should consult their healthcare provider or pharmacist regarding the continued use of this product.

Risk

The product failed to maintain its required thickness (viscosity) over time, which can affect how the medication is applied and absorbed by the skin, potentially leading to ineffective treatment of the intended area.

What You Should Do

  1. Locate your tube of Lidocaine Ointment USP, 5% (NET WT 35.44 g / 1 1/4 Oz) and check the packaging for NDC 52565-008-14.
  2. Check the crimp of the tube or the carton for Lot 13269 with an expiration date of March 2021.
  3. If your product matches Lot 13269, contact your healthcare provider or pharmacist for guidance on whether you should continue using the medication or obtain a replacement.
  4. Return any unused product from this specific lot to your pharmacy for a refund and contact Teligent Pharma, Inc. for further instructions.
  5. 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 to pharmacy

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

Affected Products

Product: Lidocaine Ointment USP, 5% (35.44 g / 1 1/4 Oz tube)
Model:
NDC 52565-008-14
Lot Numbers:
13269 (Exp March 2021)
Date Ranges: Expiration March 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87631
Status: Resolved
Manufacturer: Teligent Pharma, Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 62,040 tubes
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.