FDAFDA · Food and drugs·Recall number D-0827-2018
0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
Published May 30, 2018 · Recall initiated: November 13, 2017
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
- Distributor
- Product was distributed throughout the United States.
- Lot
- Lot # 17LU05005; Exp. 09/18 Part Number 060-10109
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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