FDA recall D-0777-2023

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

Product

Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10

Reason for recall

Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.

Distribution

Product was distributed to 32 clinics in SC, NC and VA.

Key facts

Status: Terminated
Initiation date: 2023-05-23
Report date: 2023-06-07
Termination date: 2024-05-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0777-2023