FDA Recall D-0340-2018
AuroMedics Pharma LLC · East Windsor, NJ
Class I — life-threatening Terminated 834 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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
Reason for recall
Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
Recall record
- Recall number
D-0340-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Product was distributed nationwide in the USA
- Recall initiated
- 2017-12-04
- Classified by FDA Center
- 2018-02-08
- FDA published
- 2018-02-14
- Terminated
- 2020-03-17
- Recalling firm
- AuroMedics Pharma LLC
- Firm location
- East Windsor, NJ
Drug identification
- Brand name(s)
- PANTOPRAZOLE SODIUM
- Generic name(s)
- PANTOPRAZOLE SODIUM
- Manufacturer(s)
- Eugia US LLC
- NDC(s)
55150-202- Route(s)
- INTRAVENOUS