Class I
Terminated
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
- Company
- Auromedics Pharma Llc
- Recall Initiated
- December 4, 2017
- Posted
- February 14, 2018
- Recall Number
- D-0340-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 66,100 vials
- Firm Location
- East Windsor, NJ, United States
Reason for Recall
Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
Distribution
Product was distributed nationwide in the USA
Lot / Code Info
Lot # CPO170035
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