May 2018 FDA Recall Piperacillin And Tazobactam by Auromedics Pharma Llc
D-0926-2018 - Presence of Particulate Matter

This Class I drug recall was voluntarily initiated by Auromedics Pharma Llc on May 1, 2018 for the product Piperacillin And Tazobactam. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0926-2018

Reason for Recall
Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
Initiated
05-01-2018
Reported
05-23-2018
Quantity
77,400 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79995
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AuroMedics Pharma LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
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

55150-119-30 Piperacillin And Tazobactam
55150-120-30 Piperacillin And Tazobactam
55150-121-50 Piperacillin And Tazobactam