# FDA recall D-1089-2015

> **Teva Pharmaceuticals USA** · Class I · drug recall initiated 2015-04-28.

## Product

Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-3019-11

## Reason for recall

Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1089-2015
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-04-28
- **Report date:** 2015-07-15
- **Termination date:** 2016-11-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Horsham, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1089-2015

## Citation

> AI Analytics. FDA recall D-1089-2015. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1089-2015. Source: US FDA. Licensed CC0.

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