FDA recall D-0414-2019

Akorn, Inc. · Class II · drug

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.

Distribution

Nationwide USA and Puerto Rico

Key facts

Status
Terminated
Initiation date
2018-10-08
Report date
2019-02-06
Termination date
2022-06-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0414-2019