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

FDA recall notice · announced March 20, 2019 · Akorn

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide USA and Puerto Rico
Lot/code information: Lot 7B71A, Exp 01/2020
Quantity: 51,456 bottles
Status: Terminated
Products in this recall event:
- Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10. (D-0993-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.