Medications & Supplements/Prescription Drugs

Aurobindo Pharma Ltd.: Ampicillin and Sulbactam for Injection Recalled for Glass Particles

Agency Publication Date: February 8, 2018

Summary

AuroMedics Pharma LLC is recalling 53,040 vials of Ampicillin and Sulbactam for Injection 1.5 g due to the presence of visible glass fragments found inside a vial. This prescription antibiotic is a sterile dry powder used for injections and is packaged in cartons containing 10 vials each. Consumers should be aware that the presence of glass in an injectable drug can lead to serious health complications, and healthcare providers have been notified to stop using the affected lot immediately.

Risk

If glass particles are injected, they can cause local inflammation, granulomas, or more severe issues such as the blockage of blood vessels in the heart, lungs, or brain, which can be life-threatening.

What You Should Do

Check your medical supplies for Ampicillin and Sulbactam for Injection 1.5 g vials with NDC 55150-116-20 and Lot Number AF0117001-A.
Immediately stop using any vials from the affected lot and set them aside in a secure location to ensure they are not administered.
Contact your healthcare provider or pharmacist immediately if you have received this medication and have concerns about your health or potential side effects.
Return any unused vials from the recalled lot to the pharmacy or place of purchase for a refund and further instructions.
Contact AuroMedics Pharma LLC or the manufacturer, Aurobindo Pharma Ltd., for specific instructions on how to return the product and obtain a replacement or reimbursement.
For additional questions or to report a problem, 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 product return

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 1.5 g vial, sterile

Model:

NDC 55150-116-20

D-0339-2018

Lot Numbers:

AF0117001-A

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78847

Status: Resolved

Manufacturer: Aurobindo Pharma Ltd.

Sold By: AuroMedics Pharma LLC

Manufactured In: India

Units Affected: 53,040 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

Check your medical supplies for Ampicillin and Sulbactam for Injection 1.5 g vials with NDC 55150-116-20 and Lot Number AF0117001-A.

Immediately stop using any vials from the affected lot and set them aside in a secure location to ensure they are not administered.

Contact your healthcare provider or pharmacist immediately if you have received this medication and have concerns about your health or potential side effects.

Return any unused vials from the recalled lot to the pharmacy or place of purchase for a refund and further instructions.

Contact AuroMedics Pharma LLC or the manufacturer, Aurobindo Pharma Ltd., for specific instructions on how to return the product and obtain a replacement or reimbursement.

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