Safety

Announcement

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain natural rubber latex.

For the population most at risk, those with a severe allergic reaction to latex, there is probability of an anaphylactic reaction, and this could result in hospitalization or death. To date, Fresenius Kabi USA has not received any reports of adverse events related to this recall.

Sodium Chloride Injection, USP, 0.9% is indicated for diluting or dissolving drugs for intramuscular, intravenous or subcutaneous injection according to instructions of the manufacturer of the drug to be administered. It is also indicated for use in flushing of intravenous catheters. The product is packaged as Sodium Chloride Injection, USP 0.9%, 10mL fill in a 10mL vial; Sodium Chloride Injection, USP 0.9% 20mL fill in a 20mL vial; both size vials are packaged in a 25-unit tray. See the tables below for a full list of the affected lots including lot numbers and expiration dates.

Fresenius Kabi USA is notifying its distributors and customers by letter and is arranging for return of the recalled product. If health care facilities have any of the affected lots, they are to immediately discontinue distributing, dispensing or using the lots and return all units to Fresenius Kabi. Distributors are instructed to immediately notify their customers that have been shipped, or may have been shipped, the product involved in this recall.

Consumers with questions regarding this recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to Fresenius Kabi Medical Affairs or Vigilance departments at 1-800-551-7176, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time, or send an e-mail to either productcomplaint.USA@fresenius-kabi.com or adverse.events.USA@fresenius-kabi.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Fresenius Kabi (disclaimer iconwww.fresenius-kabi.com/us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. For more information about Fresenius Kabi worldwide, please visit www.fresenius-kabi.com.

Product Name /Product sizeUnit of Sale NDC NumberUnit of Use NDC NumberProduct CodeBatch NumberExpiration Date
Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial63323-186-1063323-186-01918610601311211/2018
601311311/2018
601311411/2018
601318011/2018
601318111/2018
601318211/2018
601323701/2019
601323801/2019
601323901/2019
601346802/2019
601351202/2019
601351302/2019
601355102/2019
601355202/2019
601355302/2019
601360702/2019
601360802/2019
601361002/2019
601362703/2019
601367803/2019
601367903/2019
601382203/2019
601382303/2019
601382403/2019
601392404/2019
601392504/2019
601392604/2019
601400305/2019
601400405/2019
601400505/2019
Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial63323-186-1063323-186-01918610601426005/2019
601430105/2019
601430205/2019
601430306/2019
601430406/2019
601430506/2019
601430606/2019
601430706/2019
601438406/2019
601440406/2019
601440506/2019
601445306/2019
601445406/2019
601445506/2019
601447906/2019
601455707/2019
601455807/2019
601460607/2019
601464908/2019
601465008/2019
601470408/2019
601476608/2019
601476708/2019
601476808/2019
601484108/2019
601484208/2019
601484308/2019
601486108/2019
601486208/2019
601486308/2019
601504909/2019
601505009/2019
601508809/2019
Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial63323-186-1063323-186-01918610601511810/2019
601512710/2019
601512810/2019
601518610/2019
601518710/2019
601518810/2019
601523310/2019
601523410/2019
601523510/2019
601528511/2019
601528611/2019
601528711/2019
601540811/2019
601540911/2019
601541011/2019
601545211/2019
601545311/2019
601545411/2019
601557211/2019
601557312/2019
601557412/2019
601561612/2019
601561712/2019
601561812/2019
601592201/2020
601592301/2020
601592401/2020
601600202/2020
601600302/2020
601600402/2020
601607702/2020
601610402/2020
601620802/2020
Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial63323-186-1063323-186-01918610601620902/2020
601621002/2020
601625802/2020
601625902/2020
601626002/2020
601626102/2020
601626203/2020
601626303/2020
601626403/2020
601632303/2020
601632403/2020
601632503/2020
601638303/2020
601638403/2020
601638503/2020
601638603/2020
601638703/2020
601638803/2020
601638903/2020
601658404/2020
601658504/2020
601662104/2020
601662204/2020
601662304/2020
601676505/2020
601676605/2020
601676705/2020
601676805/2020
601676905/2020
601687506/2020
601687606/2020
601687706/2020
601687806/2020
Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial63323-186-1063323-186-01918610601687906/2020
601728806/2020
601728906/2020
601729006/2020
601729106/2020
601738207/2020
601742507/2020
601742607/2020
601742707/2020
601742807/2020
601742907/2020
601747007/2020
601747107/2020
601747207/2020
601747307/2020
601747407/2020
601767508/2020
601772508/2020
601772608/2020
Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial63323-186-2063323-186-03918620601306211/2018
601416205/2019
601416305/2019
601416405/2019
601437706/2019
601437806/2019
601437906/2019
601600502/2020
601607102/2020
601607202/2020
601607302/2020
601738307/2020
601738407/2020
601742207/2020
601742307/2020
601742407/2020

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