US Drug Recall Register
Class III · Low risk Terminated Initiated Apr 28, 2021 (5 years ago)

DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium…

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 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50) Rx only, Fresenius Medical Care NA Waltham, MA 02451

Recalling firm
Fresenius Medical Care Holdings, Inc.
NDC code
49230-0209-23
Origin
MA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0605-2021

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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