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.

Ampicillin and Sulbactam for Injection Recalled by AuroMedics Pharma LLC Due to Presence of Particulate Matter: confirmed customer report of...

Date: May 1, 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

Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ, NDC 55150-117-20.

Quantity: 54,720 vials

Why Was This Recalled?

Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.

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.

Related Recalls

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