Class II · Moderate risk Terminated
Cefuroxime 4mg /0.4 mL
Reason Lack of Assurance of Sterility
Cefuroxime
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
What was recalled
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
- Recalling firm
- JCB Laboratories LLC
- Origin
- KS, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0246-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Cefuroxime recalls
See all
Class II · Moderate risk Ongoing
CEFUROXIME INTRAVITREAL SYR 1MG/0.1ML Solution in 1 mL syringe
Reason Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk Terminated
Cefuroxime
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cefuroxime 10 mg/mL in Sodium Chloride
Reason Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
Class II · Moderate risk Terminated
Cefuroxime 10mg/mL INJ 0.5 mg
Reason Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the rubber stopper
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