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

November 20, 2018

Company Contact
Matt Kuhn
847-550-5751

FOR IMMEDIATE RELEASE – November 20, 2018 – LAKE ZURICH, Ill.— 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.

  • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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


About Fresenius Kabi

Fresenius Kabi (www.fresenius-kabi.com/us), an operating company of Fresenius, specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition worldwide. The company’s products and services are used for the therapy and care of patients with critical and chronic conditions. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us and follow us on LinkedIn and Facebook.


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

18-Nov

6013113

18-Nov

6013114

18-Nov

6013180

18-Nov

6013181

18-Nov

6013182

18-Nov

6013237

19-Jan

6013238

19-Jan

6013239

19-Jan

6013468

19-Feb

6013512

19-Feb

6013513

19-Feb

6013551

19-Feb

6013552

19-Feb

6013553

19-Feb

6013607

19-Feb

6013608

19-Feb

6013610

19-Feb

6013627

19-Mar

6013678

19-Mar

6013679

19-Mar

6013822

19-Mar

6013823

19-Mar

6013824

19-Mar

6013924

19-Apr

6013925

19-Apr

6013926

19-Apr

6014003

19-May

6014004

19-May

6014005

19-May

6014260

19-May

6014301

19-May

6014302

19-May

6014303

19-Jun

6014304

19-Jun

6014305

19-Jun

6014306

19-Jun

6014307

19-Jun

6014384

19-Jun

6014404

19-Jun

6014405

19-Jun

6014453

19-Jun

6014454

19-Jun

6014455

19-Jun

6014479

19-Jun

6014557

19-Jul

6014558

19-Jul

6014606

19-Jul

6014649

19-Aug

6014650

19-Aug

6014704

19-Aug

6014766

19-Aug

6014767

19-Aug

6014768

19-Aug

6014841

19-Aug

6014842

19-Aug

6014843

19-Aug

6014861

19-Aug

6014862

19-Aug

6014863

19-Aug

6015049

19-Sep

6015050

19-Sep

6015088

19-Sep

6015118

19-Oct

6015127

19-Oct

6015128

19-Oct

6015186

19-Oct

6015187

19-Oct

6015188

19-Oct

6015233

19-Oct

6015234

19-Oct

6015235

19-Oct

6015285

19-Nov

6015286

19-Nov

6015287

19-Nov

6015408

19-Nov

6015409

19-Nov

6015410

19-Nov

6015452

19-Nov

6015453

19-Nov

6015454

19-Nov

6015572

19-Nov

6015573

19-Dec

6015574

19-Dec

6015616

19-Dec

6015617

19-Dec

6015618

19-Dec

6015922

20-Jan

6015923

20-Jan

6015924

20-Jan

6016002

20-Feb

6016003

20-Feb

6016004

20-Feb

6016077

20-Feb

6016104

20-Feb

6016208

20-Feb

6016209

20-Feb

6016210

20-Feb

6016258

20-Feb

6016259

20-Feb

6016260

20-Feb

6016261

20-Feb

6016262

20-Mar

6016263

20-Mar

6016264

20-Mar

6016323

20-Mar

6016324

20-Mar

6016325

20-Mar

6016383

20-Mar

6016384

20-Mar

6016385

20-Mar

6016386

20-Mar

6016387

20-Mar

6016388

20-Mar

6016389

20-Mar

6016584

20-Apr

6016585

20-Apr

6016621

20-Apr

6016622

20-Apr

6016623

20-Apr

6016765

20-May

6016766

20-May

6016767

20-May

6016768

20-May

6016769

20-May

6016875

20-Jun

6016876

20-Jun

6016877

20-Jun

6016878

20-Jun

6016879

20-Jun

6017288

20-Jun

6017289

20-Jun

6017290

20-Jun

6017291

20-Jun

6017382

20-Jul

6017425

20-Jul

6017426

20-Jul

6017427

20-Jul

6017428

20-Jul

6017429

20-Jul

6017470

20-Jul

6017471

20-Jul

6017472

20-Jul

6017473

20-Jul

6017474

20-Jul

6017675

20-Aug

6017725

20-Aug

6017726

20-Aug

Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial

63323-186-20

63323-186-03

918620

6013062

18-Nov

6014162

19-May

6014163

19-May

6014164

19-May

6014377

19-Jun

6014378

19-Jun

6014379

19-Jun

6016005

20-Feb

6016071

20-Feb

6016072

20-Feb

6016073

20-Feb

6017383

20-Jul

6017384

20-Jul

6017422

20-Jul

6017423

20-Jul

6017424

20-Jul