# FDA recall D-0412-2018

> **AbbVie Inc.** · Class III · drug recall initiated 2018-01-22.

## Product

Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by:  AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51

## Reason for recall

Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.

## Distribution

MS, OH

## Key facts

- **Recall number:** D-0412-2018
- **Recalling firm:** AbbVie Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-01-22
- **Report date:** 2018-02-07
- **Termination date:** 2018-09-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0412-2018

## Citation

> AI Analytics. FDA recall D-0412-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0412-2018. Source: US FDA. Licensed CC0.

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