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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

Wells Pharma ceFAZolin Sodium Injection Recalled for Lack of Sterility Assurance

Agency Publication Date: December 6, 2023
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Summary

Wells Pharma of Houston LLC is recalling 825 syringes of ceFAZolin sodium in Sterile Water for injection (1g/10mL), a prescription medication used to treat bacterial infections. This voluntary recall was initiated due to a lack of assurance that the injectable solution is sterile. No injuries or adverse incidents have been reported to date regarding this product.

Risk

A drug intended for injection that lacks sterility assurance may contain microorganisms that can cause serious or life-threatening infections. Patients receiving this medication directly into their bloodstream are at higher risk of developing systemic illness if the product is contaminated.

What You Should Do

  1. The recalled product is ceFAZolin sodium in Sterile Water for injection, 1g/10mL (0.1 g per mL), provided in 10mL syringes with NDC 73702-131-10 and lot number 11092313110#01 (Expiration 01/12/24).
  2. Stop using the recalled product. Contact Wells Pharma of Houston LLC or your distributor immediately to arrange for the return of any remaining syringes from lot 11092313110#01.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or to report an adverse event.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: ceFAZolin sodium in Sterile Water for injection, Injectable Solution (1g/10mL)
Variants: 0.1 g per mL, Syringe, Rx only
Lot Numbers:
11092313110#01 (Exp 01/12/24)
11092313110
NDC:
73702-131-10

Quantity: 825 syringes

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93496
Status: Resolved
Manufacturer: Wells Pharma of Houston LLC
Sold By: Wells Pharma of Houston LLC
Manufactured In: United States
Units Affected: 825 syringes
Distributed To: Pennsylvania

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.