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.

Pantoprazole Sodium for Injection Recalled by AuroMedics Pharma LLC Due to Presence of Particulate Matter: One vial from a...

Date: December 4, 2017
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

Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling ROad, Dayton, NJ 08810. NDC 55150-202-00

Quantity: 66,100 vials

Why Was This Recalled?

Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass

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