# FDA recall D-0399-2015

> **Sagent Pharmaceuticals Inc** · Class II · drug recall initiated 2015-02-23.

## Product

Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-672-10

## Reason for recall

Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0399-2015
- **Recalling firm:** Sagent Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-02-23
- **Report date:** 2015-03-11
- **Termination date:** 2016-06-22

- **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-0399-2015

## Citation

> AI Analytics. FDA recall D-0399-2015. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0399-2015. Source: US FDA. Licensed CC0.

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