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Fresenius Medical Care Holdings, Inc.

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20141
20201
20218
20222
20231
20242
20251
20262
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FDA Recall Terminated Historical recordClass 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

by Fresenius Medical Care Holdings, Inc.

Reason
Temperature Abuse: Product exposed to temperature outside specified limits.
Published
June 16, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical 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.
Published
June 16, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical 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.
Published
June 16, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10

by Fresenius Medical Care Holdings, Inc.

Reason
Temperature Abuse: Product exposed to temperature outside specified limits.
Published
June 16, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451

by Fresenius Medical Care Holdings, Inc.

Reason
CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
Published
March 25, 2020
Distribution
Product was distributed throughout the U…

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FDA Recall Terminated Historical 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..
Published
May 28, 2014
Distribution
PA

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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. Read the full medical disclaimer.