PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: February 7, 2018 Initiated: January 24, 2018 #D-0246-2018

Product Description

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

Reason for Recall

Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.

Details

Recalling Firm
JCB Laboratories LLC
Units Affected
6,510 syriges
Distribution
Nationwide within USA
Location
Wichita, KS

Frequently Asked Questions

What product 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. Recalled by JCB Laboratories LLC. Units affected: 6,510 syriges.
Why was this product recalled?
Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 7, 2018. Severity: Low. Recall number: D-0246-2018.