# FDA recall D-0412-2015

> **Mylan Institutional LLC** · Class III · drug recall initiated 2015-02-11.

## Product

DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution: Cytotoxic Agent, 100 mL Multi-Dose Vial, Rx Only, Manufactured By: Onco Therapies Limited, Bangalore, 560105, INDIA, Distributed By: Amneal-Agila, LLC, Glasgow, KY, 42141, NDC 53150-317-01.

## Reason for recall

Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin Hydrochloride Injection 2 mg/mL, 100 mL

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0412-2015
- **Recalling firm:** Mylan Institutional LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-02-11
- **Report date:** 2015-03-25
- **Termination date:** 2016-02-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rockford, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0412-2015

## Citation

> AI Analytics. FDA recall D-0412-2015. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0412-2015. Source: US FDA. Licensed CC0.

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