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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/Prescription Drugs

Stanley Specialty Pharmacy Compounding and Wellness Center: Lidocaine/Tetracaine Ointment Recalled for Higher-Than-Listed Concentration

Agency Publication Date: February 10, 2021
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Summary

Stanley Specialty Pharmacy Compounding and Wellness Center is recalling 44 jars (approximately 4,400 grams) of Lidocaine/Tetracaine (LIPO110) 23%/7% Ointment. The medication was found to be superpotent, containing a higher concentration of Lidocaine than what is listed on the label. This topical prescription ointment is packaged in 100-gram (4-ounce) plastic jars and was distributed nationwide in the United States.

Risk

The superpotent formulation means patients are exposed to much higher levels of Lidocaine than intended, which can lead to systemic toxicity. High levels of Lidocaine absorption through the skin can cause serious side effects, including irregular heartbeats, seizures, or respiratory failure.

What You Should Do

  1. Check your medication jar for Lidocaine/Tetracaine (LIPO110) 23%/7% Ointment (100 GMS) with Lot number 195789 and an Expiration Date of Apr. 17 2021.
  2. Immediately stop using the affected ointment if you identify that your jar belongs to the recalled lot.
  3. Contact your healthcare provider or pharmacist for guidance regarding your treatment and to report any adverse reactions.
  4. Return any unused ointment to the pharmacy where you purchased it for a refund and contact the manufacturer for further instructions.
  5. For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Drug recall refund and consultation

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

Affected Products

Product: Lidocaine/Tetracaine (LIPO110) 23%/7% Ointment (100 GMS)
Lot Numbers:
195789 (Exp. Apr. 17 2021)
Date Ranges: Expiration Date: Apr. 17 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87255
Status: Resolved
Manufacturer: Stanley Specialty Pharmacy Compounding and Wellness Center
Sold By: Stanley Specialty Pharmacy
Manufactured In: United States
Units Affected: 4400 grams (44 jars)
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 · 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.