Home / Recalls / Akorn, Inc. / D-1878-2019

D-1878-2019 Class II Terminated

Recalled by Akorn, Inc. — Lake Forest, IL

Recall Details

Product Type
Drugs
Report Date
October 2, 2019
Initiation Date
September 17, 2019
Termination Date
August 1, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,543 tubes

Product Description

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 Pattern

Nationwide within the United States and Puerto Rico

Code Information

Lot #: 9B21A, Exp. 1/2022

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