FDA recall D-1030-2018

AuroMedics Pharma LLC · Class I · drug

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

Reason for recall

Presence of Particulate Matter: identified as glass and silicone material

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2018-07-02
Report date
2018-07-18
Termination date
2024-10-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1030-2018