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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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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Brexafemme Tablets Recalled for Potential Cross-Contamination

Agency Publication Date: October 6, 2023
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Summary

Scynexis, Inc. is recalling 17,376 units of Brexafemme (ibrexafungerp) 150 mg tablets due to potential cross-contamination. The ibrexafungerp citrate drug substance may have been contaminated with ezetimibe, which is a non-antibacterial beta-lactam compound. No incidents or injuries have been reported to date. This recall affects 4-count cartons sold at pharmacies throughout the United States.

Risk

The presence of a beta-lactam compound like ezetimibe in the medication poses a risk of severe allergic reactions or other health complications for patients with known sensitivities to beta-lactam drugs.

What You Should Do

  1. This recall affects 4-count cartons of Brexafemme (ibrexafungerp) 150 mg tablets with NDC 75788-115-04 and lot numbers LF21000008 (Exp 11/30/2023) or LF22000051 (Exp 11/30/2025).
  2. 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 Scynexis, Inc. for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

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: Brexafemme (ibrexafungerp) tablets (4 count carton)
Variants: 150 mg, Tablet
UPC Codes:
375788115049
Lot Numbers:
LF21000008 (Exp. 11/30/2023)
LF22000051 (Exp. 11/30/2025)
NDC:
75788-115-04
GTIN:
00375788115049

Rx Only medication manufactured for Scynexis, Inc.

Product Images

Carton label Brexafemme Ibrexafungerp tablets 150 mg per tablet

Carton label Brexafemme Ibrexafungerp tablets 150 mg per tablet

Blister pack label Brexafemme Ibrexafungerp tablets 150 mg per tablet

Blister pack label Brexafemme Ibrexafungerp tablets 150 mg per tablet

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93113
Status: Resolved
Manufacturer: Scynexis, Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 17,376
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 ยท FDA Press Release 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.