FDA-Drug2021-06-16Class III

DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-0212-50

Fresenius Medical Care Holdings, Inc.
Hazard

Temperature Abuse: Product exposed to temperature outside specified limits.

Sold states
Nationwide within the United States
Affected count
49 cases
Manufactured in
920 Winter St Bld 950, N/A, Waltham, MA, United States
Products
DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-0212-50

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0606-2021

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