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.

Levofloxacin in 5% Dextrose Injection Recalled by AuroMedics Pharma LLC Due to Presence of Particulate Matter; contains visible particulate matter...

Date: January 12, 2018
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

Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics Pharma LLC 6 Wheeling Drive, Dayton, NJ 08810 Manufactured for: Aurobindo Pharma Limited IDA, Pashamylaram - 502307, India ---- NDC 55150-243-46

Quantity: 6,072 bags

Why Was This Recalled?

Presence of Particulate Matter; contains visible particulate matter identified as mold.

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