# FDA recall D-66447-002

> **West-Ward Pharmaceutical Corp.** · Class II · drug recall initiated 2013-09-23.

## Product

Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Vienenburg, Germany; Distributed by: West-Ward Pharmaceutical Corp., Eatontown, NJ  07724 USA, NDC 0143-9701-01.

## Reason for recall

Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-66447-002
- **Recalling firm:** West-Ward Pharmaceutical Corp.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-09-23
- **Report date:** 2013-11-13
- **Termination date:** 2016-04-05

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-66447-002

## Citation

> AI Analytics. FDA recall D-66447-002. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-66447-002. Source: US FDA. Licensed CC0.

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