FDA recall D-0993-2019

Product

Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10.

Reason for recall

Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point.

Distribution

Nationwide USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2019-02-22

Report date

2019-03-20

Termination date

2022-08-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0993-2019