CLASS III Drug recall · Reported 7 Feb 2018 · FDA Enforcement Report
Cefuroxime, Ophthalmic Solution for Injection recalled
JCB Laboratories is recalling Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL single-use syringe, distributed nationwide in the US. The recall was initiated on 24 Jan 2018 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0246-2018
- FDA event ID
- 78962
- Recalling firm
- JCB Laboratories, Wichita, KS
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 Jan 2018
- FDA classified
- 30 Jan 2018
- Reported
- 7 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 24 Jan 2018 | Recall initiated by company | |
| 30 Jan 2018 | Classified by FDA | +6 days |
| 7 Feb 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringe. This is a Compounded Drug, Hospital & Office Use Only, Not for Resale. Fagron Sterile Services/JCB Laboratories, 7335 W. 33rd St. N., Wichita, KS 67205
Where it was distributed
Nationwide within USA
Questions about this recall
Why was it recalled?
Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
Which lots are affected?
Lot #: 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
Where was it sold?
Nationwide within USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Cefuroxime recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cefuroxime 4mg / (10 mg/mL) syringe recalled by Pine Pharmaceuticals | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Cefuroxime, Sterile Ophthalmic Solution for Injection recalled | Edge Pharma | Sterility | Nationwide |
| Drug | CLASS II | Cefuroxime 10mg/mL INJ 0.5 mg, SDV recalled | Pacific Compounding Pharmacy & Consultations | Particulate Matter | CA |
| Drug | CLASS II | Cefuroxime 10 mg/mL in Sodium Chloride recalled by Leiter's Enterprises | Leiter's Enterprises | Sterility | 4 states |
| Drug | CLASS II | Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride recalled | Leiter's Compounding | Sterility | Nationwide |