Reported Sep 21, 2016 · Terminated
Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo…
Aurobindo Pharma USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aurobindo Pharma USA Inc · 666 Plainsboro Rd Ste 210 · Plainsboro, NJ · 08536-3004
Is this the product you have?
- Pantoprazole 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) - 509302IndiaNDC 65862-0560-90
- Lot codes and dates
PSSB16011-AExp 01/18
- Amount recalled
- 23016 bottles
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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