FDAClass IIMay 3, 2023

Pantoprazole sodium for Injection 40 mg*/vial recall: CGMP Deviations

Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methapharm, Inc. Coral Springs, FL…

Why was Pantoprazole sodium for Injection 40 mg*/vial recalled?

CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.

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?

Lots: 220801; 220802; 220803 Exp. July 2024

Product
Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methapharm, Inc. Coral Springs, FL…
Recalling firm
Methapharm Inc
Quantity
5377 cartons
Distribution
Nationwide in the USA
Recall date
May 3, 2023
Classification
Class II
Status
Completed
Agency
FDA (drug)
Open FDA enforcement record Latest recalls