FDAClass IFebruary 14, 2018

Pantoprazole Sodium for Injection recall: Particulate Matter

Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling ROad…

Why was Pantoprazole Sodium for Injection recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # CPO170035

Product
Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling ROad…
Recalling firm
AuroMedics Pharma LLC
Quantity
66,100 vials
Distribution
Product was distributed nationwide in the USA
Recall date
February 14, 2018
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls