Reported Sep 14, 2022 · Terminated
Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: 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. · 5605 Centerpoint Ct Ste A · Gurnee, IL · 60031-5278
Is this the product you have?
- Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only
- Manufactured byAkorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31
- Lot codes and dates
Lot # 9J36A9J36B9J39A9J39B9J39C9J39D9J39E9J42B9J42CExp 8/31/20229K62A9K62B9K62CExp 9/30/20229M04A9M04BExp 11/30/2022
- Amount recalled
- 82,689 tubes
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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