Fresenius Medical Care Holdings, Inc. recalls 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA…
Lack of Assurance of Sterility
Read the official notice →- Date
- 2025-07-02
- Country
- United States
- Brand
- Fresenius Medical Care Holdings
- Product
- 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451,…
- Classification
- Class II
- Units
- Nationwide.
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
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