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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: Piperacillin and Tazobactam Injection Recalled for Glass and Silicone Particles

Agency Publication Date: July 11, 2018
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Summary

Approximately 73,620 vials of Piperacillin and Tazobactam for Injection USP (3.375 grams per vial) are being recalled because they may contain small particles of glass and silicone material. This prescription antibiotic is used to treat various bacterial infections, and the presence of foreign material in an injectable drug poses serious health risks. The affected vials, manufactured by AuroMedics Pharma LLC, were distributed nationwide to healthcare facilities across the United States. If you have this medication, you should consult a healthcare professional immediately.

Risk

Injecting a product containing glass or silicone particles can cause local inflammation or more severe complications such as blood vessel blockages, which could lead to organ damage or life-threatening blood clots.

What You Should Do

  1. Check your medication supply for Piperacillin and Tazobactam for Injection USP 3.375 grams per vial with NDC number 55150-120-30.
  2. Verify the lot numbers and expiration dates on the packaging: look for lot PP0317059-A (expiration February 2019) and lot PP0317012-A (expiration August 2019).
  3. If you have an affected vial, do not use it and contact your healthcare provider or pharmacist immediately for guidance and to arrange for a replacement.
  4. Return any unused product from the specified lots to the pharmacy or place of purchase for a refund.
  5. Contact the manufacturer, AuroMedics Pharma LLC, for further instructions regarding the return process.
  6. For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Refund or replacement of affected drug product.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial
Model:
NDC 55150-120-30
Lot Numbers:
PP0317059-A (Exp February 2019)
PP0317012-A (Exp August 2019)
Date Ranges: February 2019, August 2019

Product Images

Label, Auromedics Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial

Label, Auromedics Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80390
Status: Resolved
Manufacturer: AuroMedics Pharma LLC
Manufactured In: India, United States
Units Affected: 73620 single-dose vials
Distributed To: Nationwide
Agency Last Updated: August 2, 2018

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.