FDA-Drug2020-03-04Class III

Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35

Akorn, Inc.
Hazard

Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.

Sold states
Nationwide within United States and Puerto Rico
Affected count
720 tubes
Manufactured in
1925 W Field Ct Ste 300, N/A, Lake Forest, IL, United States
Products
Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0859-2020

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