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Class III · Lower riskRecall completed

Pantoprazole Sodium

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: CPO160028, Exp. June 2018
Where it was soldNationwide in US
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

Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.

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 / forAurobindo Pharma USA Inc
NDC55150-202-00
Show the full FDA record
Full product labelPantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00
Recalling firmAurobindo Pharma USA Inc
DistributionNationwide in US
Quantity29800 vials
Recall initiated2016-12-16
Report date2017-02-15
Recall completed2020-07-29
Recall numberD-0470-2017
ClassificationClass III
FDA statusTerminated
Origin on filePlainsboro 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.