Injection Recalled

Fresenius Medical Care Holdings Inc is recalling 48 cases of sodium chloride 0.9% because the product was exposed to temperatures outside specified limits, according to the June 16, 2021, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects sodium chloride 0.9%, 1000 mL (NDC 46163-300-10), from lot 20NG02095 (Exp. 10/21). The product was manufactured by Fresenius Medical Care North America, Waltham, MA, and distributed throughout the United States.

Fresenius Medical Care Holdings voluntarily initiated the recall April 28, 2021. On June 9, 2021, the FDA designated the recall Class II, communicating use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Sodium chloride 0.9% is used for parenteral replenishment of fluid and sodium chloride.