FDA recall D-0926-2018

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

Reason for recall

Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-05-01

Report date

2018-05-23

Termination date

2023-06-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0926-2018