FDA recall D-0762-2023

Sagent Pharmaceuticals Inc · Class II · drug

Product

Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide USA

Key facts

Status
Ongoing
Initiation date
2023-05-19
Report date
2023-05-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Schaumburg, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0762-2023