FDA recall D-1495-2022

Product

Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31

Reason for recall

cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.

Distribution

USA nationwide

Key facts

Status

Terminated

Initiation date

2022-08-31

Report date

2022-09-14

Termination date

2024-06-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gurnee, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1495-2022