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AuroMedics Pharma Recalls
36 recalls on record · February 14, 2018 to November 2, 2022 · Drugs
Recalls by year
18
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22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 9, 2018DrugsFDA
AuroMedics Pharma LLC recalls Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only, Distribute
Hazard: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
May 9, 2018DrugsFDA
AuroMedics Pharma LLC recalls Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion,
Hazard: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
May 9, 2018DrugsFDA
AuroMedics Pharma LLC recalls Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo Phar
Hazard: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
March 7, 2018DrugsFDA
AuroMedics Pharma LLC recalls Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufacture
Hazard: Presence of Particulate Matter; contains visible particulate matter identified as mold.
February 14, 2018DrugsFDA
AuroMedics Pharma LLC recalls Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Phar
Hazard: Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
February 14, 2018DrugsFDA
AuroMedics Pharma LLC recalls Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil la
Hazard: Presence of Particulate Matter; white particulate matter identified as mold was found in one bag