Medications & Supplements/Prescription Drugs

Hikma Pharmaceuticals USA Inc.: Sodium Chloride Injection Recalled for Failed pH Levels

Agency Publication Date: December 16, 2020

Summary

Hikma Pharmaceuticals USA Inc. is recalling 1,324,072 vials of Sodium Chloride Injection, USP, 0.9% (saline solution) due to test results showing the acidity or alkalinity (pH levels) was outside of the required specifications. This prescription medication, often used for intravenous fluid replacement or to dilute other drugs, was manufactured by West-ward in Eatontown, NJ. Consumers should immediately check their medical supplies for the affected 2mL single-dose vials and consult a healthcare provider regarding any concerns.

Risk

The pH level of an injectable medication is critical for compatibility with the human body and other drugs; out-of-specification pH levels can cause irritation at the injection site or reduce the effectiveness and stability of other medications being mixed with the saline.

What You Should Do

Identify if you have the affected Sodium Chloride Injection, USP, 0.9%, 2mL Single Dose Vials by checking the label for NDC 0641-0497-17.
Check the packaging for the following affected lot numbers and expiration dates: Lot 048315 (Exp 4/2021), Lot 068320 (Exp 6/2021), Lot 128302 (Exp 12/2021), and Lot 099349 (Exp 9/2022).
If you possess any of the affected lots, contact your healthcare provider or pharmacist immediately for guidance on alternatives and to report the affected product.
Return any unused vials from these specific lots to the pharmacy or place of purchase for a refund.
Contact Hikma Pharmaceuticals USA Inc. at their Cherry Hill, NJ office or through your medical provider for further instructions on returning the product.
For additional questions or to report a side effect, 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

Healthcare provider consultation and pharmacy 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%, 0.308 mOsmol/ml (2mL Single Dose Vial)

Model:

NDC 0641-0497-17

Lot Numbers:

048315 (Exp 4/2021)

068320 (Exp 6/2021)

128302 (Exp 12/2021)

099349 (Exp 9/2022)

Date Ranges: Expiration 4/2021, Expiration 6/2021, Expiration 12/2021, Expiration 9/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86948

Status: Resolved

Manufacturer: Hikma Pharmaceuticals USA Inc.

Sold By: hospitals; clinics; pharmacies

Manufactured In: United States

Units Affected: 1,324,072 vials

Distributed To: Nationwide

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 · 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

What You Should Do

Identify if you have the affected Sodium Chloride Injection, USP, 0.9%, 2mL Single Dose Vials by checking the label for NDC 0641-0497-17.

Check the packaging for the following affected lot numbers and expiration dates: Lot 048315 (Exp 4/2021), Lot 068320 (Exp 6/2021), Lot 128302 (Exp 12/2021), and Lot 099349 (Exp 9/2022).

If you possess any of the affected lots, contact your healthcare provider or pharmacist immediately for guidance on alternatives and to report the affected product.

Return any unused vials from these specific lots to the pharmacy or place of purchase for a refund.

Contact Hikma Pharmaceuticals USA Inc. at their Cherry Hill, NJ office or through your medical provider for further instructions on returning the product.

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