AuroMedics Pharma LLC FDA Recalls

4 recalls on file across drugs, 1 of them Class I and 1 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics PharmaClass IISep 30, 2022Subpotent Drug: Out of specification for assay	Subpotent Drug: Out of specification for assay	Class IIDrugs	Sep 30, 2022
Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedicsClass IIISep 26, 2022Presence of Particulate Matter: Piece of metal found in a vi	Presence of Particulate Matter: Piece of metal found in a vial	Class IIIDrugs	Sep 26, 2022
Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLCClass IISep 26, 2022Presence of Particulate Matter: Customer complaint for a dar	Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside	Class IIDrugs	Sep 26, 2022
Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, DClass IJan 26, 2022Presence of Particulate Matter; product complaint of hair di	Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot	Class IDrugs	Jan 26, 2022