FlaggedRx← Medication recall checkHome
Class I · Most seriousRecall completed

Pantoprazole Sodium

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot # CPO170035
Where it was soldProduct was distributed nationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byEugia US LLC
Brand namePANTOPRAZOLE SODIUM
Generic namePANTOPRAZOLE SODIUM
Active ingredient(s)PANTOPRAZOLE SODIUM
Distributed by / forAuroMedics Pharma LLC
NDC55150-202-00
Show the full FDA record
Full product labelPantoprazole 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
Recalling firmAuroMedics Pharma LLC
DistributionProduct was distributed nationwide in the USA
Quantity66,100 vials
Recall initiated2017-12-04
Report date2018-02-14
Recall completed2020-03-17
Recall numberD-0340-2018
ClassificationClass I
FDA statusTerminated
Origin on fileEast Windsor NJ United States

Related

Pantoprazole recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.