Reported Feb 6, 2019 · Terminated
Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake…
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 dropper bottle, Rx Only
- Manufactured byAkorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10
- Lot codes and dates
- Lots
6C02A Exp. 02/195K42A Exp. 09/20187D47A Exp. 03/2020
- Lots
- Amount recalled
- 149,159 5mL bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
This product could cause temporary or reversible health problems — stop using it.
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