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  4. Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex
  1. Recalls, Market Withdrawals, & Safety Alerts

COMPANY ANNOUNCEMENT

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Read Announcement

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Generic Drugs
Reason for Announcement:
Recall Reason Description
Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex
Company Name:
Fresenius Kabi USA
Brand Name:
Brand Name(s)
Fresenius Kabi
Product Description:
Product Description
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

Company 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 (www.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 size Unit of Sale NDC Number Unit of Use NDC Number Product Code Batch Number Expiration Date
Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial 63323-186-10 63323-186-01 918610 6013112 11/2018
6013113 11/2018
6013114 11/2018
6013180 11/2018
6013181 11/2018
6013182 11/2018
6013237 01/2019
6013238 01/2019
6013239 01/2019
6013468 02/2019
6013512 02/2019
6013513 02/2019
6013551 02/2019
6013552 02/2019
6013553 02/2019
6013607 02/2019
6013608 02/2019
6013610 02/2019
6013627 03/2019
6013678 03/2019
6013679 03/2019
6013822 03/2019
6013823 03/2019
6013824 03/2019
6013924 04/2019
6013925 04/2019
6013926 04/2019
6014003 05/2019
6014004 05/2019
6014005 05/2019
Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial 63323-186-10 63323-186-01 918610 6014260 05/2019
6014301 05/2019
6014302 05/2019
6014303 06/2019
6014304 06/2019
6014305 06/2019
6014306 06/2019
6014307 06/2019
6014384 06/2019
6014404 06/2019
6014405 06/2019
6014453 06/2019
6014454 06/2019
6014455 06/2019
6014479 06/2019
6014557 07/2019
6014558 07/2019
6014606 07/2019
6014649 08/2019
6014650 08/2019
6014704 08/2019
6014766 08/2019
6014767 08/2019
6014768 08/2019
6014841 08/2019
6014842 08/2019
6014843 08/2019
6014861 08/2019
6014862 08/2019
6014863 08/2019
6015049 09/2019
6015050 09/2019
6015088 09/2019
Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial 63323-186-10 63323-186-01 918610 6015118 10/2019
6015127 10/2019
6015128 10/2019
6015186 10/2019
6015187 10/2019
6015188 10/2019
6015233 10/2019
6015234 10/2019
6015235 10/2019
6015285 11/2019
6015286 11/2019
6015287 11/2019
6015408 11/2019
6015409 11/2019
6015410 11/2019
6015452 11/2019
6015453 11/2019
6015454 11/2019
6015572 11/2019
6015573 12/2019
6015574 12/2019
6015616 12/2019
6015617 12/2019
6015618 12/2019
6015922 01/2020
6015923 01/2020
6015924 01/2020
6016002 02/2020
6016003 02/2020
6016004 02/2020
6016077 02/2020
6016104 02/2020
6016208 02/2020
Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial 63323-186-10 63323-186-01 918610 6016209 02/2020
6016210 02/2020
6016258 02/2020
6016259 02/2020
6016260 02/2020
6016261 02/2020
6016262 03/2020
6016263 03/2020
6016264 03/2020
6016323 03/2020
6016324 03/2020
6016325 03/2020
6016383 03/2020
6016384 03/2020
6016385 03/2020
6016386 03/2020
6016387 03/2020
6016388 03/2020
6016389 03/2020
6016584 04/2020
6016585 04/2020
6016621 04/2020
6016622 04/2020
6016623 04/2020
6016765 05/2020
6016766 05/2020
6016767 05/2020
6016768 05/2020
6016769 05/2020
6016875 06/2020
6016876 06/2020
6016877 06/2020
6016878 06/2020
Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial 63323-186-10 63323-186-01 918610 6016879 06/2020
6017288 06/2020
6017289 06/2020
6017290 06/2020
6017291 06/2020
6017382 07/2020
6017425 07/2020
6017426 07/2020
6017427 07/2020
6017428 07/2020
6017429 07/2020
6017470 07/2020
6017471 07/2020
6017472 07/2020
6017473 07/2020
6017474 07/2020
6017675 08/2020
6017725 08/2020
6017726 08/2020
Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial 63323-186-20 63323-186-03 918620 6013062 11/2018
6014162 05/2019
6014163 05/2019
6014164 05/2019
6014377 06/2019
6014378 06/2019
6014379 06/2019
6016005 02/2020
6016071 02/2020
6016072 02/2020
6016073 02/2020
6017383 07/2020
6017384 07/2020
6017422 07/2020
6017423 07/2020
6017424 07/2020

 

Company Contact Information

Consumers:
Fresenius Kabi USA Quality Assurance
1-866-716-2459
Media:
Matt Kuhn
847-550-5751
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