IV Bags Recalled

A lack of assurance of sterility has caused Nephron Sterile Compounding Center to voluntarily recall 9410 intravenous bags containing fentanyl citrate injection. The recall is included in the July 27, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects fentanyl citrate in 0.9% sodium chloride injection, 2500 mcg/250 mL (10 mcg/mL) bags, packaged as 10 x 1 intravenous bags per case (NDC 69374-523-21), from lots FN2001A (Exp. 7/8/22), FN2001B (Exp. 7/8/22), FN2002A (Exp. 7/19/22), FN2002B (Exp. 7/19/22), FN2003A (Exp. 8/24/22), and FN2003B (Exp. 8/24/22).

Nephron Sterile Compounding Center initiated the recall June 30, 2022. On July 18, 2022, the FDA designated the recall Class II. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Fentanyl citrate is a potent opioid agonist used during anesthesia.