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
Reported: February 15, 2017 Initiated: December 16, 2016 #D-0470-2017
Product Description
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
Reason for Recall
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Details
- Recalling Firm
- Aurobindo Pharma USA Inc
- Units Affected
- 29800 vials
- Distribution
- Nationwide in US
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Aurobindo Pharma USA Inc. Units affected: 29800 vials.
Why was this product recalled? ▼
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 15, 2017. Severity: Low. Recall number: D-0470-2017.
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