Reported Oct 2, 2019 · Terminated
Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, 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. · 1925 W Field Ct Ste 300 · Lake Forest, IL · 60045-4862
Is this the product you have?
- Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile
- Manufactured byAkorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30
- Lot codes and dates
Lot #: 9B21AExp. 1/2022
- Amount recalled
- 10,543 tubes
Where it was sold
- Nationwide
- PR
Why it was recalled
cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line.
This product could cause temporary or reversible health problems — stop using it.
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