Reported Mar 20, 2019 · Terminated
Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL…
Akorn, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akorn, Inc. · 1925 W Field Ct Ste 300 · Lake Forest, IL · 60045-4862
Is this the product you have?
- Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only
- Manufactured forAkorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10
- Lot codes and dates
Lot 7B71AExp 01/2020
- Amount recalled
- 51,456 bottles
Where it was sold
- Nationwide
- PR
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.
This product could cause temporary or reversible health problems — stop using it.
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