FDA-Drug2023-06-07Class II
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
Fresenius Medical Care Holdings, Inc.
Hazard
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
Sold states
Product was distributed to 32 clinics in SC, NC and VA.
Affected count
53,424 bags
Manufactured in
920 Winter St Bld 950, N/A, Waltham, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0777-2023Don't want to check this manually?
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