FDA recall D-1878-2019

Akorn, Inc. · Class II · drug

Product

Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30

Reason for recall

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.

Distribution

Nationwide within the United States and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2019-09-17
Report date: 2019-10-02
Termination date: 2022-08-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1878-2019