US Drug Recall Register
Class I · High risk Terminated Initiated Jan 26, 2022 (5 years ago)

Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials…

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

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

What was recalled

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

Recalling firm
AuroMedics Pharma LLC
NDC code
55150-234-10
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0556-2022

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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