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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

AuroMedics Pharma LLC: Ampicillin and Sulbactam for Injection Recalled for Red Rubber Particles

Agency Publication Date: May 10, 2018
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Summary

AuroMedics Pharma LLC is recalling 54,720 vials of Ampicillin and Sulbactam for Injection, USP (3 grams/vial), a sterile antibiotic used for intramuscular or intravenous injection. The recall was initiated after a customer reported finding visible red rubber particles inside a vial, which are believed to have originated from the manufacturing process of the active ingredients. Consumers should immediately stop using these vials and contact their healthcare provider or pharmacist, as the presence of foreign particulate matter in an injectable drug can lead to serious health complications.

Risk

Injecting a product containing particulate matter can cause local inflammation, phlebitis, or the blockage of blood vessels, which may lead to serious events like pulmonary embolism or stroke. One customer has already confirmed the presence of visible red rubber particles in the medication.

What You Should Do

  1. Check your medication vials for NDC 55150-117-20 and the following specific lot numbers: AS0317041-A or AS0317035-A.
  2. Verify if your vials have an expiration date of August 2019 (Exp August 2019).
  3. Immediately stop using any vials from the affected lots and set them aside to ensure they are not administered.
  4. Contact your healthcare provider or pharmacist for guidance regarding your treatment and to report any adverse reactions.
  5. Return any unused vials from these lots to the pharmacy where they were purchased for a refund.
  6. Contact AuroMedics Pharma LLC at 1-888-723-3332 for further instructions on how to handle or return the recalled product.
  7. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

๐Ÿ’ฐFull 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: Ampicillin and Sulbactam for Injection, USP (3 grams/vial)
Model:
NDC 55150-117-20
Lot Numbers:
AS0317041-A (Exp August 2019)
AS0317035-A (Exp August 2019)
Date Ranges: August 2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79996
Status: Resolved
Manufacturer: AuroMedics Pharma LLC
Sold By: hospitals; clinics
Manufactured In: United States
Units Affected: 54,720 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 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.