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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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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

ICU Medical Inc: Aminosyn II 15% Injection Recalled for Foreign Particulate Matter

Agency Publication Date: September 15, 2021
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Summary

ICU Medical Inc. is recalling 2,112 flexible containers of Aminosyn II 15% (An Amino Acid Injection, Sulfite-Free) because visible foreign particles were discovered in sample units. The particles were identified as hair, fibers, and proteinaceous material, which should not be present in an injectable medication. This prescription drug was distributed nationwide across the United States. Consumers should check their supply immediately for the affected lot and contact their healthcare provider or pharmacist regarding any unused product.

Risk

Injecting a medication containing particulate matter like hair or fibers can cause serious health issues, including inflammation, allergic reactions, or the blockage of blood vessels, which could lead to life-threatening complications like a stroke or heart attack.

What You Should Do

  1. Identify your product by checking for Aminosyn II 15% (An Amino Acid Injection, Sulfite-Free) in 2000 mL flexible containers with NDC 0409-7171-17.
  2. Check the packaging for Lot Number 4989094 with an expiration date of 01-APR-2022 to see if your supply is part of the recall.
  3. Stop using any affected medication immediately and contact your healthcare provider or pharmacist for guidance on alternative treatments.
  4. Return any unused or affected containers to your pharmacy or the place of purchase for a refund.
  5. Contact ICU Medical Inc. for further instructions regarding the return or disposal of the product.
  6. 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

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: AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free (2000 mL)
Model:
NDC 0409-7171-17
Recall #: D-0805-2021
Lot Numbers:
4989094 (Exp. 01-APR-2022)
Date Ranges: Expiration Date: 01-APR-2022

Product Images

Image 1 - Label, Aminosyn II, 15%, An Amino Acid Injection, Sulfite

Image 1 - Label, Aminosyn II, 15%, An Amino Acid Injection, Sulfite

Image 2 - Label, Aminosyn II, 15%, An Amino Acid Injection, Sulfite

Image 2 - Label, Aminosyn II, 15%, An Amino Acid Injection, Sulfite

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88620
Status: Resolved
Manufacturer: ICU Medical Inc
Sold By: Hospira, Inc.
Manufactured In: United States
Units Affected: 2,112 Flexible Containers
Distributed To: Nationwide
Agency Last Updated: September 17, 2021

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.