0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.

FDA recall notice · announced May 30, 2018 · Fresenius Medical Care Renal Therapies Group

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.

Reason for recall

Lack of Assurance of Sterility

Notes

Distribution: Product was distributed throughout the United States.
Lot/code information: Lot # 17LU05005; Exp. 09/18 Part Number 060-10109
Quantity: 25,356 1 liter bags
Status: Terminated
Products in this recall event:
- 0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10. (D-0827-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.