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Fresenius Medical Care Holdings, Inc. — DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.
Do not stop taking this without speaking to your pharmacist or doctor.
What’s wrong
Lack of Sterility Assurance
The Recall Registry rates this serious — FDA Class II: temporary or medically reversible health harm.
What to do
Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.
Who to contact: Recalling firm: Fresenius Medical Care Holdings, Inc.
The product
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.
Details
- Units affected
- 69,590 bags
- Recall date
- December 28, 2023
- Brand
- Fresenius Medical Care Holdings, Inc.
Nationwide within the United States
The official notice
This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.
Their exact wording: “Fresenius Medical Care Holdings, Inc. — DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.”
Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.
Filed under: Prescription medicine