FDA recall D-1496-2022

Akorn, Inc. · Class II · drug

Product

Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35

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-1496-2022