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

First paragraph, first sentence of release dated November 20, 2018, the number of lots being recalled should read 164 lots (instead of 163 lots). An additional table has also been added listing the lots being recalled.

The corrected release reads:

FRESENIUS KABI ISSUES VOLUNTARY NATIONWIDE RECALL OF SODIUM CHLORIDE INJECTION, USP, 0.9% DUE TO PRODUCT LABELING INCORRECTLY STATING STOPPERS DO NOT CONTAIN LATEX

Fresenius Kabi USA is voluntarily recalling 164 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.

 Stay Updated To Save Money & Time. Join Our Free Newsletter 
. Indepth Analysis & Opinion       . Interviews      . Exclusive Reports  
. Free Digital Magazines      News & updates      . Event Invitations 
                     
& Much More Delivered To Your Inbox For Free.
Submit
We Will Not Spam, Rent, or Sell Your Information.
All emails include an unsubscribe link. You may opt-out at any time. See our privacy policy.

 

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 [email protected] or [email protected].

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.

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 companys products and services are used to help care for critically and chronically ill patients. The companys U.S. headquarters is in Lake Zurich, Illinois. The companys 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

 

Unit of Use NDC

 

Product

 

Batch

 

Expiration

   

Number

 

Number

 

Code

 

Number

 

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
                     

Product Name/Product size

 

Unit of Sale NDC

 

Unit of Use NDC

 

Product

 

Batch

 

Expiration

   

Number

 

Number

 

Code

 

Number

 

Date

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
                     

Product Name/Product size

 

Unit of Sale NDC

 

Unit of Use NDC

 

Product

 

Batch

 

Expiration

   

Number

 

Number

 

Code

 

Number

 

Date

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
                     

Product Name/Product size

 

Unit of Sale NDC

 

Unit of Use NDC

 

Product

 

Batch

 

Expiration

   

Number

 

Number

 

Code

 

Number

 

Date

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
                     

Product Name/Product size

 

Unit of Sale NDC

 

Unit of Use NDC

 

Product

 

Batch

 

Expiration

   

Number

 

Number

 

Code

 

Number

 

Date

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
                     

Product Name/Product size

 

Unit of Sale

 

Unit of Use NDC

 

Product

 

Batch

 

Expiration

   

NDC Number

 

Number

 

Code

 

Number

 

Date

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
Matt Kuhn
847-550-5751

 Stay Updated To Save Money & Time. Join Our Free Newsletter 
. Indepth Analysis & Opinion       . Interviews      . Exclusive Reports  
. Free Digital Magazines      News & updates      . Event Invitations 
                     
& Much More Delivered To Your Inbox For Free.
Submit
We Will Not Spam, Rent, or Sell Your Information.
All emails include an unsubscribe link. You may opt-out at any time. See our privacy policy.

 
Close
Stay Updated To Save Money & Time. Join Our Free Newsletter. 
. Indepth Analysis & Opinion       Interviews          . Exclusive Reports 
. Free Digital Magazines        . News & updates        . Event Invitations
& Much More Delivered To Your Inbox For Free. 
Submit
We Will Not Spam, Rent, or Sell Your Information.
All emails include an unsubscribe link. You may opt-out at any time. See our privacy policy.
 
Close