AuroMedics Pharma LLC

5 FDA enforcement actions

5 Total Recalls

1 Class I

3 Class II

1 Class III

Firm Details

Product Types: drug
States: NJ

All Recalls

Class II: Risk 09/30/2022 drug

Subpotent Drug: Out of specification for assay
Class III: Low Risk 09/26/2022 drug

Presence of Particulate Matter: Piece of metal found in a vial
Class II: Risk 09/26/2022 drug

Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Class I: Dangerous 01/26/2022 drug

Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Class II: Risk 12/30/2020 drug

Discoloration and failed pH specifications

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.