FDA-Drug2019-10-02Class II
Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30
Akorn, Inc.
Hazard
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.
Sold states
Nationwide within the United States and Puerto Rico
Affected count
10,543 tubes
Manufactured in
1925 W Field Ct Ste 300, Lake Forest, IL, United States
Products
Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1878-2019Don't want to check this manually?
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