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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

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

Agency Publication Date: November 18, 2020
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Summary

Hikma Pharmaceuticals USA Inc. has recalled approximately 2,100,646 units of Sodium Chloride Injection USP 0.9% (2 mL vials) used as a sterile diluent. This prescription drug was recalled because test results showed the pH levels were outside of the required safety specifications, which could affect the stability or efficacy of the medication being diluted. This nationwide recall includes specific lots of single-dose vials manufactured by West-ward in Eatontown, New Jersey.

Risk

Using a sterile diluent with incorrect pH levels can potentially cause irritation at the injection site or change the effectiveness of the drug it is mixed with. While no injuries have been reported, the deviation from set chemical standards poses a risk to patient safety during medical procedures.

What You Should Do

  1. Check your medical supplies for Sodium Chloride Injection, USP, 0.9% 2mL Single Dose Vials with the following vial lot numbers: 078338 (Exp. 7/2021), 088391 (Exp. 08/2021), 098340 (Exp. 09/2021), 108325 (Exp. 10/2021), or 010018 (Exp. 1/2023).
  2. Check carton packaging for lot number 068322 (Exp. 06/2021) and confirm if the NDC numbers match 0641-0497-17 (Vial) or 0641-0497-25 (Carton).
  3. Contact your healthcare provider or pharmacist immediately for guidance if you believe you have used or possess these affected vials.
  4. Return any unused product to the pharmacy or place of purchase for a refund and contact Hikma Pharmaceuticals USA Inc. for further instructions regarding product return.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

๐Ÿ’ฐFull Refund

Return unused product 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% 2mL Single Dose Vial
Model:
NDC 0641-0497-17
NDC 0641-0497-25
Lot Numbers:
078338 (Exp. 7/2021)
088391 (Exp. 08/2021)
098340 (Exp. 09/2021)
108325 (Exp. 10/2021)
010018 (Exp. 1/2023)
068322 (Exp. 06/2021)
Date Ranges: Expiration 06/2021, Expiration 07/2021, Expiration 08/2021, Expiration 09/2021, Expiration 10/2021, Expiration 01/2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86685
Status: Resolved
Manufacturer: Hikma Pharmaceuticals USA Inc.
Sold By: Hospitals; Pharmacies; Healthcare Providers
Manufactured In: United States
Units Affected: 2,100,646 Vials
Distributed To: Nationwide
Agency Last Updated: November 20, 2020

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 ยท 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.