# FDA recall D-392-2014

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2013-10-11.

## Product

Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose Vial, Rx ONLY, For IV Use Only, Manufactured By: Teva parenteral Medicines, Inc., Irvine, CA NOVAPlus¿¿ labels.  NDC 0703-5233-13 (carton), NDC 0703-5233-11 (vial) or NDC 0703-5233-93 (carton), NDC 0703-5233-91 (vial)

## Reason for recall

Presence of Precipitate; precipitation of drug product

## Distribution

Nationwide

## Key facts

- **Recall number:** D-392-2014
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-10-11
- **Report date:** 2014-01-08
- **Termination date:** 2014-08-27

- **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-392-2014

## Citation

> AI Analytics. FDA recall D-392-2014. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-392-2014. Source: US FDA. Licensed CC0.

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