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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 Erythromycin Topical Gel Recalled for Impurity Specifications

Agency Publication Date: February 17, 2022
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Summary

Teligent Pharma, Inc. is recalling 11,040 tubes of Erythromycin Topical Gel USP, 2% (30 g tube) because testing revealed the product contained unidentified related compounds that exceeded approved safety and quality limits. Erythromycin is a topical prescription antibiotic used to treat skin conditions like acne. This recall affects one specific lot of the gel manufactured in the United States.

Risk

Using medication that contains unknown impurities or degradation products may result in reduced effectiveness of the treatment or unexpected skin irritation. No incidents or adverse reactions have been reported to date in connection with this issue.

What You Should Do

  1. The recalled product is Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, with NDC 63739-053-66, lot number 15724, and an expiration date of 06/2022.
  2. Identify your product by checking the 30 g tube or the outer carton for lot number 15724 and expiration date 06/2022.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Erythromycin Topical Gel USP, 2% (30 g tube)
Variants: Topical Gel, 2%, 30 g tube
Lot Numbers:
15724 (Exp. 06/2022)
NDC:
63739-053-66

Recall #: D-0716-2022. Distributed by McKesson Corporation dba Sky Packaging.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89560
Status: Resolved
Manufacturer: Teligent Pharma, Inc.
Sold By: McKesson Corporation; Sky Packaging; Pharmacies
Manufactured In: United States
Units Affected: 11040 tubes
Distributed To: Nationwide
Agency Last Updated: March 24, 2022

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.