# FDA recall D-1308-2020

> **Hikma Pharmaceuticals USA Inc.** · Class II · drug recall initiated 2020-06-11.

## Product

Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9701-01

## Reason for recall

Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-1308-2020
- **Recalling firm:** Hikma Pharmaceuticals USA Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-06-11
- **Report date:** 2020-06-24
- **Termination date:** 2021-06-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cherry Hill, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1308-2020

## Citation

> AI Analytics. FDA recall D-1308-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1308-2020. Source: US FDA. Licensed CC0.

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