Product: Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10
Reason for recall: Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Recall initiated: 20181008
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated