FDA-Drug2021-06-16Class III
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius Medical Care NA, Waltham, MA 02451
Fresenius Medical Care Holdings, Inc.
Hazard
Temperature Abuse: Product exposed to temperature outside specified limits.
Sold states
Nationwide within the United States
Affected count
285 cases
Manufactured in
920 Winter St Bld 950, N/A, Waltham, MA, United States
Products
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius Medical Care NA, Waltham, MA 02451
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0610-2021Don't want to check this manually?
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