Piperacillin And Tazobactam Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 55150-121
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Piperacillin And Tazobactam (NDC 55150-121). A significant event, classified as Class I, was initiated on Jul 02, 2018 by Eugia Us Llc. The reported reason for this action was: "Presence of Particulate Matter: identified as glass and silicone material"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Presence of Particulate Matter: identified as glass and silicone material
Jul 02, 2018
Jul 18, 2018
73620 single-dose vials
Recall Profile & Regulatory Data
Event ID
80390
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
AuroMedics Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Oct 01, 2024
Product Description
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
Batch or Lot Expiration Information
Lot# Lot: PP0317059-A; Exp February 2019: PP0317012-A, Exp: August 2019.
Affected Packages Involved in this Recall
55150-119-30Product
55150-120-30Product
55150-121-50Product
Class I Terminated
Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
May 01, 2018
May 23, 2018
77,400 vials
Recall Profile & Regulatory Data
Event ID
79995
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
AuroMedics Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jun 21, 2023
Product Description
Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx Only, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ 05610. NDC 55150-120-30
Batch or Lot Expiration Information
Lot# s: PP0317061-A, PP0317049-A; EXP August 2019
Affected Packages Involved in this Recall
55150-119-30Product
55150-120-30Product
55150-121-50Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
