D-1878-2019 Class II Terminated
FDA drug recall D-1878-2019 was initiated by Akorn, Inc. on September 17, 2019 and is designated Class II. 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, b… The recall status is terminated (terminated August 1, 2022). Affected quantity: 10,543 tubes.
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