Class II
Terminated
Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30
- Company
- Akorn, Inc.
- Recall Initiated
- September 17, 2019
- Posted
- October 2, 2019
- Recall Number
- D-1878-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 10,543 tubes
- Firm Location
- Lake Forest, IL, United States
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
Lot / Code Info
Lot #: 9B21A, Exp. 1/2022
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