# FDA recall D-1615-2014

> **Sagent Pharmaceuticals Inc** · Class II · drug recall initiated 2014-03-04.

## Product

Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenous Infusion, Mfd. for Sagent Pharmaceuticals Schaumburg, IL ---- NDC 25021-830-82

## Reason for recall

Lack of Assurance of Sterility; leaking of premix bags

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1615-2014
- **Recalling firm:** Sagent Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-03-04
- **Report date:** 2014-10-08
- **Termination date:** 2016-07-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Schaumburg, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1615-2014

## Citation

> AI Analytics. FDA recall D-1615-2014. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-1615-2014. Source: US FDA. Licensed CC0.

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