FDA-Drug2018-02-14Class I

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

AuroMedics Pharma LLC
Hazard

Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass

Sold states
Product was distributed nationwide in the USA
Affected count
66,100 vials
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0340-2018

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