DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Temperature Abuse: Product exposed to temperature outside specified limits.
What was recalled
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- NDC code
- 49230-0188-50
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0604-2021
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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