Class III
Terminated
Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00
This recall has been terminated (originally issued February 15, 2017).
- Company
- Aurobindo Pharma Usa Inc
- Recall Initiated
- December 16, 2016
- Posted
- February 15, 2017
- Recall Number
- D-0470-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 29800 vials
- Firm Location
- Plainsboro, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Distribution
Nationwide in US
Lot / Code Info
Lot #: CPO160028, Exp. June 2018
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