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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.: Erythromycin Topical Solution and Gel Recalled for Failed Impurities Specs

Agency Publication Date: July 20, 2021
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Summary

Teligent Pharma, Inc. is recalling 30,696 units of Erythromycin Topical Solution USP, 2% (60 mL) and Erythromycin Topical Gel, 2% (30 g and 60 g). These prescription medications were found to fail required tests for impurities and degradation specifications during stability testing. Using a product that has degraded may mean the medication is less effective at treating skin conditions like acne or contains higher-than-allowed levels of chemical breakdown products. Consumers should contact their healthcare provider or pharmacist for guidance on alternative treatments and return the affected products to their place of purchase for a refund.

Risk

The medications failed to meet chemical stability standards, which can lead to the formation of impurities or the breakdown of the active ingredients. While the risk level is considered low, degraded medication may not work properly to treat the intended condition.

What You Should Do

  1. Check your prescription bottles or tubes for the product name Erythromycin Topical Solution USP, 2% or Erythromycin Topical Gel, 2%.
  2. For the 60 mL Topical Solution, look for lot number 14180 with NDC 52565-027-59 on the label.
  3. For the 30 g Topical Gel, look for lot number 14010 with an expiration date of July 2021 (NDC 52565-033-30).
  4. For the 60 g Topical Gel, look for lot numbers 13865 (Exp June 2021) or 14011 (Exp July 2021) with NDC 52565-033-60.
  5. Immediately stop using any products that match the specified lot numbers and expiration dates.
  6. Contact your healthcare provider or pharmacist to discuss continuing your treatment with a different lot or alternative medication.
  7. Return any unused portion of the recalled medication to the pharmacy where you purchased it for a refund.
  8. For further questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Consult health provider and return product.

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

Affected Products

Product: Erythromycin Topical Solution USP, 2% (60 mL)
Model:
NDC 52565-027-59
Lot Numbers:
14180
Product: Erythromycin Topical Gel, 2% (30 g)
Model:
NDC 52565-033-30
Lot Numbers:
14010 (Exp July 2021)
Date Ranges: July 2021
Product: Erythromycin Topical Gel, 2% (60 g)
Model:
NDC 52565-033-60
Lot Numbers:
13865 (Exp June 2021)
14011 (Exp July 2021)
Date Ranges: June 2021, July 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88145
Status: Resolved
Manufacturer: Teligent Pharma, Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 2 products (7872 tubes; 22,824 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.