PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: May 23, 2018 Initiated: May 1, 2018 #D-0926-2018

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

Reason for Recall

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

Details

Recalling Firm
AuroMedics Pharma LLC
Units Affected
77,400 vials
Distribution
Nationwide in the USA
Location
East Windsor, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by AuroMedics Pharma LLC. Units affected: 77,400 vials.
Why was this product recalled?
Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
Which agency issued this recall?
This recall was issued by the FDA Drug on May 23, 2018. Severity: Critical. Recall number: D-0926-2018.