0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10
Reported: July 2, 2025 Initiated: May 27, 2025 #D-0490-2025
Product Description
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Units Affected
- 3,651,468 containers
- Distribution
- Nationwide.
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 3,651,468 containers.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 2, 2025. Severity: Moderate. Recall number: D-0490-2025.
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