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.
Product description
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
Lot numbers, UPCs & expiration codes
PSSB16011-A, Exp 01/18
Where it was sold
CA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1499-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 3, 2016
- FDA report date
- Sep 21, 2016
- Quantity
- 23016 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma USA Inc
Original FDA data
Every field from FDA enforcement report D-1499-2016, exactly as published.
Show all FDA fields
- City
- Plainsboro
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 74949
- Address
- 666 Plainsboro Rd Ste 210
- Code information
- PSSB16011-A, Exp 01/18
- Postal code
- 08536-3004
- Report date
- Sep 21, 2016
- Product type
- Drugs
- Recall number
- D-1499-2016
- Classification
- Class II
- Recalling firm
- Aurobindo Pharma USA Inc
- Product quantity
- 23016 bottles
- Termination date
- Jun 8, 2018
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- CA
- Recall initiation date
- Aug 3, 2016
- Initial firm notification
- Letter
- Center classification date
- Sep 14, 2016