FDA recall D-0246-2018

Product

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.

Distribution

Nationwide within USA

Key facts

Status

Terminated

Initiation date

2018-01-24

Report date

2018-02-07

Termination date

2020-08-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wichita, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0246-2018