Class II Recall

Nephron Sterile Compounding Center LLC

Product
Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL*) bags, packaged as 10 x 1 IV bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21
Reason
Lack of Assurance of Sterility
Classification
Class II
Status
Terminated
Lot
Lots: FN2001A, Exp. 7/8/2022; FN2001B, Exp. 7/8/2022; FN2002A, Exp. 7/19/2022; FN2002B, Exp. 7/19/2022; FN2003A, Exp. 8/24/2022; FN2003B, Exp. 8/24/2022
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.