0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10

FDA recall notice · announced December 14, 2022 · Fresenius Medical Care

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

The product

0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10

Reason for recall

Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.

Notes

Distribution: Product was distributed Nationwide in the USA.
Lot/code information: Lot # 22HU05062, 22HU06059, 22HU05035, EXP 06/30/2023; 22JU05001, EXP 07/31/2023
Quantity: 4,097 cases/12 bags per case
Status: Ongoing
Products in this recall event:
- 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 0 (D-0075-2023)

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