FDA recall D-0075-2023

Fresenius Medical Care Holdings, Inc. · Class II · drug

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.

Distribution

Product was distributed Nationwide in the USA.

Key facts

Status: Ongoing
Initiation date: 2022-11-22
Report date: 2022-12-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0075-2023