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Baxter Healthcare Corporation

Recalls

Recalls by year

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

Recalls by year
YearRecalls
20151
20161
20177
20188
20194
20201
20221
20237
20244
20251
20261
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FDA Recall Terminated Historical recordClass III

Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-047-24.

by Baxter Healthcare Corporation

Reason
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Published
August 15, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24.

by Baxter Healthcare Corporation

Reason
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Published
August 15, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10

by Baxter Healthcare Corporation

Reason
Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
Published
February 7, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fresenius Kabi, Uppsala, Sweden for Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0519-58

by Baxter Healthcare Corporation

Reason
Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.
Published
November 1, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B1309, NDC: 0338-0049-38

by Baxter Healthcare Corporation

Reason
Lack of Assurance of Sterility: Bags have the potential to leak.
Published
July 19, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B0089, NDC: 0338-0017-38

by Baxter Healthcare Corporation

Reason
Lack of Assurance of Sterility: Bags have the potential to leak.
Published
July 19, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Distributed in Canada by Baxter Corporation, Toronto, Ontario, Canada, Product Code: 2B1322, NDC 0338-0049-02.

by Baxter Healthcare Corporation

Reason
Lack of Assurance of Sterility: Customer complaints for leaking bags.
Published
July 19, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-6010-48

by Baxter Healthcare Corporation

Reason
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Published
May 24, 2017
Distribution
US and foreign countries: United Arab Em…

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FDA Recall Terminated Historical recordClass II

Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48

by Baxter Healthcare Corporation

Reason
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Published
May 24, 2017
Distribution
US and foreign countries: United Arab Em…

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FDA Recall Terminated Historical recordClass II

10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, NDC 0338-1130-06

by Baxter Healthcare Corporation

Reason
Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.
Published
January 18, 2017
Distribution
US

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FDA Recall Terminated Historical recordClass II

Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48.

by Baxter Healthcare Corporation

Reason
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Published
December 28, 2016
Distribution
United States, United Arab Emirates, and…

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FDA Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38

by Baxter Healthcare Corporation

Reason
Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.
Published
September 30, 2015
Distribution
Nationwide

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This page lists recalls that name Baxter Healthcare Corporation 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.