Recalls / Class II
Class IID-1499-2016
Product
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
- Affected lot / code info
- PSSB16011-A, Exp 01/18
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.
Recalling firm
- Firm
- Aurobindo Pharma USA Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 666 Plainsboro Rd Ste 210, N/A, Plainsboro, New Jersey 08536-3004
Distribution
- Quantity
- 23016 bottles
- Distribution pattern
- CA
Timeline
- Recall initiated
- 2016-08-03
- FDA classified
- 2016-09-14
- Posted by FDA
- 2016-09-21
- Terminated
- 2018-06-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1499-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.