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Based on the official records currently available to Public Health Trace, 7 recalls naming Fresenius Medical Care Holdings, Inc. are currently shown as ongoing. The other 11 records below are historical.
Public Health Trace has 18 recalls naming Fresenius Medical Care Holdings, Inc. as the recalling firm, republished from official FDA and USDA sources.
Recall records - 18 total
Recalls by year
A bar chart of the number of recalls naming this company by year.
FDA RecallTerminatedTerminated: September 17, 2021Historical recordClass III
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
by Fresenius Medical Care Holdings, Inc.
Reason
Temperature Abuse: Product exposed to temperature outside specified limits.
FDA RecallTerminatedTerminated: September 17, 2021Historical recordClass III
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
by Fresenius Medical Care Holdings, Inc.
Reason
Temperature Abuse: Product exposed to temperature outside specified limits.
FDA RecallTerminatedTerminated: August 13, 2015Historical recordClass II
phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for Fresenius Medical Care North America, Waltham, MA 02451, NDC 0781-2081-02
by Fresenius Medical Care Holdings, Inc.
Reason
Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle. Chemical analysis of the contaminant found on the cotton was identified as a formulation of 4% Trimipramine methanesulfonate - a tricyclic antidepressant..
Some FDA recall records on this page come from FDA's Enforcement Report database.
Not every Enforcement Report record has a separate FDA.gov recall-announcement page.
This page lists recalls that name Fresenius Medical Care Holdings, Inc. as the recalling firm in the official source notice. It is
not a safety rating, ranking, or statement that the company acted negligently.
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