# FDA recall D-1334-2015

> **Mylan Institutional LLC** · Class I · drug recall initiated 2015-03-23.

## Product

Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL  61103, Made in India, NDC 67457-462-01, UPC 3 67457 46201 1.

## Reason for recall

Presence of Particulate Matter

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1334-2015
- **Recalling firm:** Mylan Institutional LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-03-23
- **Report date:** 2015-08-26
- **Termination date:** 2016-05-20

- **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-1334-2015

## Citation

> AI Analytics. FDA recall D-1334-2015. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1334-2015. Source: US FDA. Licensed CC0.

---

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