# FDA recall D-0819-2016

> **Fresenius Kabi USA, LLC** · Class II · drug recall initiated 2016-04-05.

## Product

Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC  Lake Zurich, IL 60047, NDC 63323-417-10

## Reason for recall

Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label.  The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0819-2016
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-04-05
- **Report date:** 2016-04-20
- **Termination date:** 2017-04-11

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0819-2016

## Citation

> AI Analytics. FDA recall D-0819-2016. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0819-2016. Source: US FDA. Licensed CC0.

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