# FDA recall D-0891-2018

> **Ingenus Pharmaceuticals Llc** · Class II · drug recall initiated 2018-06-08.

## Product

Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-401-02.

## Reason for recall

Superpotent Drug: High out of specification assay value results for potency.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0891-2018
- **Recalling firm:** Ingenus Pharmaceuticals Llc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-06-08
- **Report date:** 2018-07-11
- **Termination date:** 2019-05-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Orlando, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0891-2018

## Citation

> AI Analytics. FDA recall D-0891-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0891-2018. Source: US FDA. Licensed CC0.

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