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
Reported: February 14, 2018 Initiated: December 4, 2017 #D-0340-2018
Product Description
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
Details
- Recalling Firm
- AuroMedics Pharma LLC
- Units Affected
- 66,100 vials
- Distribution
- Product was distributed nationwide in the USA
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by AuroMedics Pharma LLC. Units affected: 66,100 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 14, 2018. Severity: Critical. Recall number: D-0340-2018.
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