July 2018 FDA Recall Piperacillin And Tazobactam by Auromedics Pharma Llc
D-1030-2018 - Presence of Particulate Matter
This Class I drug recall was voluntarily initiated by Auromedics Pharma Llc on July 2, 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-1030-2018
Presence of Particulate Matter: identified as glass and silicone material
07-02-2018
07-18-2018
73620 single-dose vials
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
10-01-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
