# FDA recall D-1059-2019

> **Mylan Institutional Inc** · Class I · drug recall initiated 2019-02-01.

## Product

Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for:  Mylan Institutional LLC, Rockford, IL 61103 U.S.A., Made in India.  NDC: 67457-601-30

## Reason for recall

Presence of Particulate Matter: particulate matter identified as copper salts

## Distribution

Nationwide in the United States

## Key facts

- **Recall number:** D-1059-2019
- **Recalling firm:** Mylan Institutional Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-02-01
- **Report date:** 2019-03-20
- **Termination date:** 2020-06-19

- **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-1059-2019

## Citation

> AI Analytics. FDA recall D-1059-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1059-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*