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
D-1878-2019
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 83721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,543 tubes
- Official record key
drug-enforcement:D-1878-2019
Official wording
Reason: 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.
Code information: Lot #: 9B21A, Exp. 1/2022
Distribution pattern: Nationwide within the United States and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
particulate matter
-
Manufacturing or process control
cGMP Deviations