Class II
Terminated
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
This recall has been terminated (originally issued September 21, 2016).
- Company
- Aurobindo Pharma Usa Inc
- Recall Initiated
- August 3, 2016
- Posted
- September 21, 2016
- Recall Number
- D-1499-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 23016 bottles
- Firm Location
- Plainsboro, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
CA
Lot / Code Info
PSSB16011-A, Exp 01/18
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