Drug recall
Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for…
FDA recall event 78696 · Class I · AuroMedics Pharma LLC
Key facts
| Event ID | 78696 |
|---|---|
| Recall numbers | D-0340-2018 |
| Recalling firm | AuroMedics Pharma LLC |
| Product type | Drugs |
| Products | Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling ROad, Dayton, NJ 08810. NDC 55150-202-00 |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass |
| Initiation date | Dec 4, 2017 |
| Report date | Feb 14, 2018 |
| Termination date | Mar 17, 2020 |
| City | East Windsor |
| State | NJ |
| Country | United States |
| FEI number | 3014054088 |
At a glance
- 1–9 Products in this recall
- None 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: