Drug recall D-0556-2022

Class I Terminated reported Feb 16, 2022

Product

Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, Distributed by: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-234-10

Reason for recall

Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot

Lots and codes

Lot CPB200013, exp 9/2022

Recall details

Recalling firm
AuroMedics Pharma LLC, East Windsor, NJ
Quantity
35,520 vials
Distribution
Nationwide in the US
Type
Voluntary: Firm initiated
Recall initiated
January 26, 2022
Terminated
August 20, 2024

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