AuroMedics Pharma LLC Recalls — U.S. Recall Records

Recall history in this database

Classification mix: Class II: 14, Class I: 9, Class III: 7.

DrugMay 9, 2018

Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% recall — FDA D-0708-2018

Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

Class IIFDA: TerminatedAuroMedics Pharma LLC

DrugMay 9, 2018

Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration recall — FDA D-0703-2018

Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

Class IIFDA: TerminatedAuroMedics Pharma LLC

DrugMay 9, 2018

Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For recall — FDA D-0706-2018

Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

Class IIFDA: TerminatedAuroMedics Pharma LLC

DrugMar 7, 2018

Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible recall — FDA D-0574-2018

Presence of Particulate Matter; contains visible particulate matter identified as mold.

Class IFDA: TerminatedAuroMedics Pharma LLC

DrugFeb 14, 2018

Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible recall — FDA D-0337-2018

Presence of Particulate Matter; white particulate matter identified as mold was found in one bag

Class IFDA: TerminatedAuroMedics Pharma LLC

DrugFeb 14, 2018

Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial recall — FDA D-0340-2018

Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass

Class IFDA: TerminatedAuroMedics Pharma LLC

Understanding this recall history

This page summarizes recall records in which the official source identifies AuroMedics Pharma LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.