# FDA recall D-0470-2017

> **Aurobindo Pharma USA Inc** · Class III · drug recall initiated 2016-12-16.

## Product

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.

## Distribution

Nationwide in US

## Key facts

- **Recall number:** D-0470-2017
- **Recalling firm:** Aurobindo Pharma USA Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-12-16
- **Report date:** 2017-02-15
- **Termination date:** 2020-07-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plainsboro, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0470-2017

## Citation

> AI Analytics. FDA recall D-0470-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0470-2017. Source: US FDA. Licensed CC0.

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