Medications & Supplements/Prescription Drugs

Fresenius Kabi USA, LLC: Sodium Chloride Injection Recalled for Latex Content Labeling Error

Agency Publication Date: December 6, 2018

Summary

Fresenius Kabi USA is recalling approximately 25,057,650 vials of Sodium Chloride Injection, USP, 0.9%, because the product labels and inserts incorrectly state that the vial stoppers do not contain natural rubber latex. In reality, the stoppers for these specific batches do contain natural rubber latex, which was not disclosed to healthcare providers or patients. This voluntary recall affects 10 mL and 20 mL single-dose vials distributed nationwide across the United States and Puerto Rico.

Risk

Patients with a known sensitivity or allergy to natural rubber latex may experience a severe allergic reaction (anaphylaxis) if they are treated with these products. Because the labeling incorrectly claims the product is latex-free, healthcare providers may inadvertently use it on latex-sensitive patients, posing a critical risk of injury or death.

What You Should Do

Check your inventory for Sodium Chloride Injection, USP, 0.9%, 10 mL Single Dose Vials (NDC 63323-186-10, Product Code 918610) or 20 mL Single Dose Vials (NDC 63323-186-20, Product Code 918620).
Verify the lot numbers on your 10 mL vials against the affected list, which includes over 100 codes such as 6013112, 6013113, 6013114, 6013180, 6014003, 6015049, 6016002, 6017288, and 6017726 with expiration dates ranging from 11/2018 to 08/2020.
Verify the lot numbers on your 20 mL vials, specifically lots 6013062, 6014162, 6014163, 6014164, 6014377, 6014378, 6014379, 6016005, 6016071, 6016072, 6016073, 6017383, 6017384, 6017422, 6017423, and 6017424.
If you identify affected product, stop using it immediately and contact your healthcare provider or pharmacist for guidance regarding alternative medications.
Return any unused product to the pharmacy or place of purchase for a refund and contact Fresenius Kabi USA for further instructions on the return process.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact healthcare provider and return for refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial

Model:

NDC 63323-186-10

Product code 918610

Lot Numbers (148):

6013112 (Exp 11/2018)

6013113 (Exp 11/2018)

6013114 (Exp 11/2018)

6013180 (Exp 11/2018)

6013181 (Exp 11/2018)

6013182 (Exp 11/2018)

6013237 (Exp 01/2019)

6013238 (Exp 01/2019)

6013239 (Exp 01/2019)

6013468 (Exp 02/2019)

6013512 (Exp 02/2019)

6013513 (Exp 02/2019)

6013551 (Exp 02/2019)

6013552 (Exp 02/2019)

6013553 (Exp 02/2019)

6013607 (Exp 02/2019)

6013608 (Exp 02/2019)

6013610 (Exp 02/2019)

6013627 (Exp 03/2019)

6013678 (Exp 03/2019)

6013679 (Exp 03/2019)

6013822 (Exp 03/2019)

6013823 (Exp 03/2019)

6013824 (Exp 03/2019)

6013924 (Exp 04/2019)

6013925 (Exp 04/2019)

6013926 (Exp 04/2019)

6014003 (Exp 05/2019)

6014004 (Exp 05/2019)

6014005 (Exp 05/2019)

6014260 (Exp 05/2019)

6014301 (Exp 05/2019)

6014302 (Exp 05/2019)

6014303 (Exp 06/2019)

6014304 (Exp 06/2019)

6014305 (Exp 06/2019)

6014306 (Exp 06/2019)

6014307 (Exp 06/2019)

6014384 (Exp 06/2019)

6014404 (Exp 06/2019)

6014405 (Exp 06/2019)

6014453 (Exp 06/2019)

6014454 (Exp 06/2019)

6014455 (Exp 06/2019)

6014479 (Exp 06/2019)

6014557 (Exp 07/2019)

6014558 (Exp 07/2019)

6014606 (Exp 07/2019)

6014649 (Exp 08/2019)

6014650 (Exp 08/2019)

Date Ranges: Expiration dates between 11/2018 and 08/2020

Product: SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial

Model:

NDC 63323-186-20

Product code 918620

Lot Numbers:

6013062 (Exp 11/2018)

6014162 (Exp 05/2019)

6014163 (Exp 05/2019)

6014164 (Exp 05/2019)

6014377 (Exp 06/2019)

6014378 (Exp 06/2019)

6014379 (Exp 06/2019)

6016005 (Exp 02/2020)

6016071 (Exp 02/2020)

6016072 (Exp 02/2020)

6016073 (Exp 02/2020)

6017383 (Exp 07/2020)

6017384 (Exp 07/2020)

6017422 (Exp 07/2020)

6017423 (Exp 07/2020)

6017424 (Exp 07/2020)

Date Ranges: Expiration dates between 11/2018 and 07/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81570

Status: Resolved

Manufacturer: Fresenius Kabi USA, LLC

Sold By: Authorized hospital and pharmacy distributors

Manufactured In: United States

Units Affected: 2 products (23,745,300 10 mL vials; 1,312,350 20 mL vials)

Distributed To: Nationwide

Agency Last Updated: December 14, 2018

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your inventory for Sodium Chloride Injection, USP, 0.9%, 10 mL Single Dose Vials (NDC 63323-186-10, Product Code 918610) or 20 mL Single Dose Vials (NDC 63323-186-20, Product Code 918620).

Verify the lot numbers on your 10 mL vials against the affected list, which includes over 100 codes such as 6013112, 6013113, 6013114, 6013180, 6014003, 6015049, 6016002, 6017288, and 6017726 with expiration dates ranging from 11/2018 to 08/2020.

Verify the lot numbers on your 20 mL vials, specifically lots 6013062, 6014162, 6014163, 6014164, 6014377, 6014378, 6014379, 6016005, 6016071, 6016072, 6016073, 6017383, 6017384, 6017422, 6017423, and 6017424.

If you identify affected product, stop using it immediately and contact your healthcare provider or pharmacist for guidance regarding alternative medications.

Return any unused product to the pharmacy or place of purchase for a refund and contact Fresenius Kabi USA for further instructions on the return process.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial

Model:

NDC 63323-186-10

Product code 918610

Lot Numbers (148):

6013112 (Exp 11/2018)

6013113 (Exp 11/2018)

6013114 (Exp 11/2018)

6013180 (Exp 11/2018)

6013181 (Exp 11/2018)

6013182 (Exp 11/2018)

6013237 (Exp 01/2019)

6013238 (Exp 01/2019)

6013239 (Exp 01/2019)

6013468 (Exp 02/2019)

6013512 (Exp 02/2019)

6013513 (Exp 02/2019)

6013551 (Exp 02/2019)

6013552 (Exp 02/2019)

6013553 (Exp 02/2019)

6013607 (Exp 02/2019)

6013608 (Exp 02/2019)

6013610 (Exp 02/2019)

6013627 (Exp 03/2019)

6013678 (Exp 03/2019)

6013679 (Exp 03/2019)

6013822 (Exp 03/2019)

6013823 (Exp 03/2019)

6013824 (Exp 03/2019)

6013924 (Exp 04/2019)

6013925 (Exp 04/2019)

6013926 (Exp 04/2019)

6014003 (Exp 05/2019)

6014004 (Exp 05/2019)

6014005 (Exp 05/2019)

6014260 (Exp 05/2019)

6014301 (Exp 05/2019)

6014302 (Exp 05/2019)

6014303 (Exp 06/2019)

6014304 (Exp 06/2019)

6014305 (Exp 06/2019)

6014306 (Exp 06/2019)

6014307 (Exp 06/2019)

6014384 (Exp 06/2019)

6014404 (Exp 06/2019)

6014405 (Exp 06/2019)

6014453 (Exp 06/2019)

6014454 (Exp 06/2019)

6014455 (Exp 06/2019)

6014479 (Exp 06/2019)

6014557 (Exp 07/2019)

6014558 (Exp 07/2019)

6014606 (Exp 07/2019)

6014649 (Exp 08/2019)

6014650 (Exp 08/2019)

Date Ranges: Expiration dates between 11/2018 and 08/2020

Product: SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial

Model:

NDC 63323-186-20

Product code 918620

Lot Numbers:

6013062 (Exp 11/2018)

6014162 (Exp 05/2019)

6014163 (Exp 05/2019)

6014164 (Exp 05/2019)

6014377 (Exp 06/2019)

6014378 (Exp 06/2019)

6014379 (Exp 06/2019)

6016005 (Exp 02/2020)

6016071 (Exp 02/2020)

6016072 (Exp 02/2020)

6016073 (Exp 02/2020)

6017383 (Exp 07/2020)

6017384 (Exp 07/2020)

6017422 (Exp 07/2020)

6017423 (Exp 07/2020)

6017424 (Exp 07/2020)

Date Ranges: Expiration dates between 11/2018 and 07/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81570

Status: Resolved

Manufacturer: Fresenius Kabi USA, LLC

Sold By: Authorized hospital and pharmacy distributors

Manufactured In: United States

Units Affected: 2 products (23,745,300 10 mL vials; 1,312,350 20 mL vials)

Distributed To: Nationwide

Agency Last Updated: December 14, 2018