November 19, 2021, Sagent Pharma announces a voluntary nationwide recall of Levetiracetam Injection. Four lots of Levetiracetam was recalled due to the lack of a sterile product. Issues pertaining to container closure integrity was brought to attention when found in reserve sample vials. Sagent Pharmaceuticals did not follow USP suggested guidelines for container closure integrity—distributing damaged lots of Levetiracetam Injection. This mistake could be life threatening due to improper container closure, particles could become more and more present in the product over time.
With InQuest Science’s Identifier software, it is designed to help prevent recalls like these. Inspection is done properly and checked by a supervisor. Data integrity issues like this will be harder to falsify, all data imported/ altered into the system is tracked. Inspectors will be tested for assurance of following USP <790> and <1790> guidelines for visual inspection.
Sagent Pharmaceuticals notifies customers by fax, email and mail. They are given details for return of the 4 recalled lots.
To learn more information about the recall read the full company announcement published on FDA.gov