FDA Recall Terminated Historical recordClass II
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
- 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.
- Published
- March 20, 2019
- Distribution
- Nationwide
