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 and…

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 and attached stay safe Exchange set, packaged in a) 2500 mL (NDC 49230-209-94) and b) 2000mL, packs of 5 (NDC 49230-209-92) Fresenius Medical Care NA, Waltham, MA 02451,

Recalling firm
Fresenius Medical Care Holdings, Inc.
NDC code
49230-209-94
Origin
MA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0608-2021

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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