MedicineWatch US

AuroMedics Pharma LLC Provisional

East Windsor, NJ · united states

4 recall flag(s), 1 Class I

FDA Flags (4)

Class II RecallNov 2022
AuroMedics Pharma LLC
Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma
Classification: Class II
Class II RecallOct 2022
AuroMedics Pharma LLC
Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC
Classification: Class II
Class III RecallOct 2022
AuroMedics Pharma LLC
Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics
Classification: Class III
Class I RecallFeb 2022
AuroMedics Pharma LLC
Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, D
Classification: Class I