Class II · Moderate risk Ongoing
Gentamicin Injection
Reason Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Gentamicin Sulfate Ophthalmic Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
What was recalled
Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10.
- Recalling firm
- Akorn, Inc.
- NDC code
- 17478-283-10
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0993-2019
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Gentamicin recalls
See all
Class II · Moderate risk Terminated
Gentamicin Bladder 0.08mg/Ml
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
Gentamicin Sulfate Cream USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Gentamicin Sulfate Ointment USP 0.1%
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Gentamicin Sulfate Cream USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.