CLASS I Drug recall · Reported 18 Jul 2018 · FDA Enforcement Report
Piperacillin and Tazobactam for Injection USP per vial recalled
AuroMedics Pharma is recalling Piperacillin and Tazobactam for Injection USP per vial, Single-Dose Vial, distributed nationwide in the US. The recall was initiated on 2 Jul 2018 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1030-2018
- FDA event ID
- 80390
- Recalling firm
- AuroMedics Pharma, East Windsor, NJ
- Manufacturer
- Eugia US LLC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 2 Jul 2018
- FDA classified
- 2 Aug 2018
- Reported
- 18 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Antibiotics
Timeline
| 2 Jul 2018 | Recall initiated by company | |
| 18 Jul 2018 | Published in enforcement report | +16 days |
| 2 Aug 2018 | Classified by FDA | +15 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: identified as glass and silicone material
Product as listed by the FDA
Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx Only. Manufactured for: Auromedics Pharma LLC 6 Wheeling Road Dayton NJ 08810, Made in India. NDC 55150-120-30
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: identified as glass and silicone material
Which lots are affected?
Lot: PP0317059-A; Exp February 2019: PP0317012-A, Exp: August 2019.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from AuroMedics Pharma
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fondaparinux Sodium Injection, USP, 7.5 mg per, Single Dose recalledFondaparinux Sodium | AuroMedics Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Acyclovir Sodium Injection, 500mg/ (50mg/mL) Single Dose Vial recalledAcyclovir Sodium | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS III | Tranexamic Acid Injection, USP, 1000mg recalled by AuroMedics PharmaTranexamic Acid | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS I | Polymyxin B for Injection USP per Vial vials recalledPolymyxin B | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS II | Acetaminophen Injection 1,000 mg recalled by AuroMedics PharmaAcetaminophen | AuroMedics Pharma | Other | Nationwide |
Other Piperacillin recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Piperacillin and Tazobactam for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Piperacillin and Tazobactam for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Piperacillin and Tazobactam for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Piperacillin and Tazobactam for Injection, UPS per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Piperacillin and Tazobactam for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |