Drug recall
Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for…
FDA recall event 74949 · Class II · Aurobindo Pharma USA Inc
Key facts
| Event ID | 74949 |
|---|---|
| Recall numbers | D-1499-2016 |
| Recalling firm | Aurobindo Pharma USA Inc |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Aug 3, 2016 |
| Report date | Sep 21, 2016 |
| Termination date | Jun 8, 2018 |
| City | Plainsboro |
| State | NJ |
| Country | United States |
| FEI number | 3004859679 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: