# FDA recall D-0495-2017

> **AbbVie Inc.** · Class II · drug recall initiated 2017-01-13.

## Product

Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette, 7 cassettes per carton, Rx Only, AbbVie Inc., North Chicago, IL 60064 --- NDC 0074-3012-07

## Reason for recall

Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life

## Distribution

TN and IL

## Key facts

- **Recall number:** D-0495-2017
- **Recalling firm:** AbbVie Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-01-13
- **Report date:** 2017-03-08
- **Termination date:** 2019-03-15

- **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-0495-2017

## Citation

> AI Analytics. FDA recall D-0495-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0495-2017. Source: US FDA. Licensed CC0.

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