FDAFDA · Food and drugs·Recall number D-0777-2023
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
Published June 7, 2023 · Recall initiated: May 23, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Distributor
- Product was distributed to 32 clinics in SC, NC and VA.
- Lot
- Lot # 23AU05030, Exp 01/13/2024; 23AU05035, Exp 01/15/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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