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Class II · ModerateRecall completed

Pantoprazole Sodium Delayed-Release Tablets USP

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberPSSB16011-A, Exp 01/18
Where it was soldCA
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 Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole.

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 byAurobindo Pharma Limited Unit-VII (SE2), Mahaboob Nagar (Dt) - 509302, India foreign manufacturer
Distributed by / forAurobindo Pharma USA, Inc 2400 Route 130 North Dayton, NJ 08810
NDC65862-0560-90
Show the full FDA record
Full product labelPantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo Pharma USA, Inc 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit-VII (SE2), Mahaboob Nagar (Dt) - 509302, India , NDC 65862-0560-90
Recalling firmAurobindo Pharma USA Inc
DistributionCA
Quantity23016 bottles
Recall initiated2016-08-03
Report date2016-09-21
Recall completed2018-06-08
Recall numberD-1499-2016
ClassificationClass II
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.