# FDA recall D-0916-2018

> **Akorn, Inc.** · Class II · drug recall initiated 2018-06-22.

## Product

Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.

## Reason for recall

CGMP Deviations

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-0916-2018
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-06-22
- **Report date:** 2018-07-18
- **Termination date:** 2020-11-06

- **Voluntary/Mandated:** —
- **Location:** Decatur, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0916-2018

## Citation

> AI Analytics. FDA recall D-0916-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0916-2018. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
