0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
Reported: May 30, 2018 Initiated: November 13, 2017 #D-0827-2018
Product Description
0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Units Affected
- 25,356 1 liter bags
- Distribution
- Product was distributed throughout the United States.
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.. Recalled by Fresenius Medical Care Renal Therapies Group, LLC. Units affected: 25,356 1 liter bags.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 30, 2018. Severity: Moderate. Recall number: D-0827-2018.
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