Polymyxin B Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 55150-234
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Polymyxin B (NDC 55150-234). A significant event, classified as Class I, was initiated on Jan 26, 2022 by Eugia Us Llc. The reported reason for this action was: "Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
January 2022 Class I Recall: Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Recall Number
Class I Terminated
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Jan 26, 2022
Feb 16, 2022
35,520 vials
Recall Profile & Regulatory Data
Event ID
89457
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
AuroMedics Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
Aug 20, 2024
Product Description
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
Batch or Lot Expiration Information
Lot# Lot CPB200013, exp 9/2022
Affected Packages Involved in this Recall
55150-234-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
