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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/Prescription Drugs

JCB Laboratories LLC: Cefuroxime Injection Recalled for Subpotency Concerns

Agency Publication Date: January 30, 2018
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Summary

JCB Laboratories is recalling 6,510 syringes of Cefuroxime (ophthalmic solution for injection), 10 mg/mL, 0.3 mL single-use syringes. This compounded medication is used in hospitals and medical offices for injection into the eye. The recall was issued because the drug may become sub-potent (weaker than intended) before its 90-day beyond use date. Because this product is for hospital and office use only, patients should contact their healthcare provider or pharmacist regarding any procedures involving this medication.

Risk

If the medication is sub-potent, it may not provide the full intended dose of antibiotic to the patient, potentially leading to ineffective treatment of infections during or after eye surgery.

What You Should Do

  1. Check your medical facility's inventory for Cefuroxime Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringes with any of the following lot numbers: C274-000002725, C274-000002790, C274-000002989, C274-000003008, or C274-000003077.
  2. Verify the Beyond Use Dates (BUD) on the packaging, specifically looking for dates 1/21/2018, 1/28/2018, 2/13/2018, 2/14/2018, or 2/20/2018.
  3. If you are a patient and believe you received this medication, contact your healthcare provider or pharmacist for guidance.
  4. Hospitals and clinics should immediately stop using these specific lots and return any unused syringes to the place of purchase for a refund.
  5. Contact JCB Laboratories/Fagron Sterile Services at 7335 W. 33rd St. N., Wichita, KS 67205 for further instructions on returning the product.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider guidance and product return.

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

Affected Products

Product: Cefuroxime, Ophthalmic Solution for Injection (0.3 mL single-use syringe)
Model:
Recall #: D-0246-2018
Lot Numbers:
C274-000002725 (BUD 1/21/2018)
C274-000002790 (BUD 1/28/2018)
C274-000002989 (BUD 2/13/2018)
C274-000003008 (BUD 2/14/2018)
C274-000003077 (BUD 2/20/2018)
Date Ranges: BUD 1/21/2018, BUD 1/28/2018, BUD 2/13/2018, BUD 2/14/2018, BUD 2/20/2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78962
Status: Resolved
Manufacturer: JCB Laboratories LLC
Sold By: Hospitals; Medical Offices
Manufactured In: United States
Units Affected: 6,510 syriges
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.