Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Polymyxin B for Injection USP Recalled by AuroMedics Pharma LLC Due to Presence of Particulate Matter; product complaint of hair...

Date: January 26, 2022
Company: AuroMedics Pharma LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact AuroMedics Pharma LLC directly.

Affected Products

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

Quantity: 35,520 vials

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About AuroMedics Pharma LLC

AuroMedics Pharma LLC has 36 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report