FDAFDA · Food and drugs·Recall number D-1499-2016
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) - 509302, India , NDC 65862-0560-90
Published September 21, 2016 · Recall initiated: August 3, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aurobindo Pharma USA Inc
- Distributor
- CA
- Lot
- PSSB16011-A, Exp 01/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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