# FDA recall D-1351-2015

> **Teva Pharmaceuticals USA** · Class I · drug recall initiated 2015-07-24.

## Product

ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by Teva Parenteral Medicines, Inc., Irvine, CA. NDC 073-3019-11 (individual vial), NDC 0703-3019-12 (carton of five).

## Reason for recall

Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-1351-2015
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-07-24
- **Report date:** 2015-09-02
- **Termination date:** 2016-11-02

- **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-1351-2015

## Citation

> AI Analytics. FDA recall D-1351-2015. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1351-2015. Source: US FDA. Licensed CC0.

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